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NCT Number: NCT04722796

HANGZHOU Solution in Bicuspid AS Undergoing TAVR

To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial

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Key information

Conditions

Aortic Stenosis Aortic Stenosis With Bicuspid Valve Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First affiliated hospital of bengbu medical college, Bengbu, Anhui, China

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About this study

Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.

Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV.

Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low.

The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years
  • Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
  • Severe, bicuspid aortic stenosis:
  • Mean gradient ≥40 mmHg
  • Maximal aortic valve velocity ≥4.0 m/sec
  • Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
  • NYHA classification ≥ II;
  • Type 0, type 1 (Sievers classification) by MDCT
  • Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
  • Transfemoral TAVR
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.

Exclusion criteria

  • Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
  • Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL).
  • Active sepsis, including active bacterial endocarditis with or without treatment;
  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  • Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
  • Estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
  • Any Emergent surgery required before TAVR procedure.
  • A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media
  • Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  • Subject refuses a blood transfusion.
  • Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  • Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
  • Currently participating in an investigational drug or another device study (excluding registries).
  • Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Severe mitral stenosis amenable to surgical replacement or repair.
  • Aortic valve type cannot be determined (Sievers classification).
  • Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation>70°).
  • Ascending aorta diameter > 50 mm.
  • Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
  • Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
  • Previous pacemaker implantation.

Treatment and study plan

TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

Device

Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

Other names: Hangzhou solution

TAVR with Venus A plus using annular sizing and THV implantation technique

Device

Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)

Other names: Traditional sizing strategy (Annulus based sizing strategy)

Primary outcomes

  1. Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month

    Time frame: 1 month

    Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 [VARC-2] criteria)

Secondary outcomes

  1. Deaths (all-cause mortality) at 1 month

    Time frame: 1 month

    Number of deaths from any cause mortality at 1 month

  2. Deaths (all-cause mortality) at 1 year

    Time frame: 1 year

  3. Deaths (all-cause mortality) at 2 years

    Time frame: 2 years

  4. Deaths (all-cause mortality) at 3 years

    Time frame: 3 years

  5. Deaths (all-cause mortality) at 4 years

    Time frame: 4 years

  6. Deaths (all-cause mortality) at 5 years

    Time frame: 5 years

  7. All Stroke (disabling and non-disabling) at 1 month

    Time frame: 1 month

    duration of a focal or global neurological deficit >24 h; OR <24 h if available neuroimaging documents a new haemorrhage or infarct; OR the neurological deficit results in death

  8. All Stroke (disabling and non-disabling) at 1 year

    Time frame: 1 year

  9. All Stroke (disabling and non-disabling) at 2 years

    Time frame: 2 years

  10. All Stroke (disabling and non-disabling) at 3 years

    Time frame: 3 years

  11. All Stroke (disabling and non-disabling) at 4 years

    Time frame: 4 years

  12. All Stroke (disabling and non-disabling) at 5 years

    Time frame: 5 years

  13. Rate of New permanent pacemaker implantation at 1 month

    Time frame: 1 month

    Rate of New permanent pacemaker implantation (e.g. defibrillator, single vs. dual chamber, biventricular)

  14. Rate of New permanent pacemaker implantation at 1 year

    Time frame: 1 year

  15. Rate of New permanent pacemaker implantation at 2 years

    Time frame: 2 years

  16. Rate of New permanent pacemaker implantation at 3 years

    Time frame: 3 years

  17. Rate of New permanent pacemaker implantation at 4 years

    Time frame: 4 years

  18. Rate of New permanent pacemaker implantation at 5 years

    Time frame: 5 years

  19. Rate of Moderate or severe prosthetic valve regurgitation at 1 month

    Time frame: 1 month

    Moderate or severe prosthetic valve regurgitation by transthoracic echocardiography, VARC-2 definition

  20. Rate of Moderate or severe prosthetic valve regurgitation at 1 year

    Time frame: 1 year

  21. Rate of Moderate or severe prosthetic valve regurgitation at 2 years

    Time frame: 2 years

  22. Rate of Moderate or severe prosthetic valve regurgitation at 3 years

    Time frame: 3 years

  23. Rate of Moderate or severe prosthetic valve regurgitation at 4 years

    Time frame: 4 years

  24. Rate of Moderate or severe prosthetic valve regurgitation at 5 years

    Time frame: 5 years

  25. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 month

    Time frame: 1 month

    Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications by VARC-2 definition

  26. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 year

    Time frame: 1 year

  27. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 2 years

    Time frame: 2 years

  28. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 3 years

    Time frame: 3 years

  29. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 4 years

    Time frame: 4 years

  30. Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 5 years

    Time frame: 5 years

  31. Rate of alternating valve of prosthetic valve size during TAVR

    Time frame: peri-procedural

    Alternating valve of prosthetic valve size during TAVR (up size or down size)

  32. Rate of valve malposition

    Time frame: peri-procedural

    Valve malposition (migration, embolization, and ectopic deployment)

  33. Rate of TAV-in-TAV deployment

    Time frame: peri-procedural

    TAV-in-TAV deployment (An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function, during the index procedure)

  34. Rate of device recapture or retrieval

    Time frame: peri-procedural

    Device recapture or retrieval peri-procedural

  35. Rate of conversion to open surgery

    Time frame: peri-procedural

    Conversion to open surgery (Conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications)

  36. Rate of unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure

    Time frame: peri-procedural

    Unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure

  37. Rate of coronary obstruction

    Time frame: peri-procedural

    Coronary obstruction (Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during the TAVR procedure)

  38. Major vascular complications (VARC 2)

    Time frame: peri-procedural

    Major vascular complications by VARC 2 definition

  39. Rate of annulus rupture

    Time frame: peri-procedural

    Procedural-related injuries occur in the region of the aortic root and the left ventricular outflow tract during transcatheter aortic valve replacement.

  40. Rate of structural valve deterioration at 1 month

    Time frame: 1 month

    Structural valve deterioration (2017 EAPCI/ESC/EACTS definition)

  41. Rate of structural valve deterioration at 1 year

    Time frame: 1 year

  42. Rate of structural valve deterioration at 2 years

    Time frame: 2 years

  43. Rate of structural valve deterioration at 3 years

    Time frame: 3 years

  44. Rate of structural valve deterioration at 4 years

    Time frame: 4 years

  45. Rate of structural valve deterioration at 5 years

    Time frame: 5 years

  46. New onset complete LBBB before discharge

    Time frame: before discharge

    New onset complete LBBB, by 2009 AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III definition

  47. New onset complete LBBB at 1 month

    Time frame: 1 month

  48. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at Baseline

    Time frame: Baseline

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  49. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 month

    Time frame: 1 month

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  50. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 year

    Time frame: 1 year

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  51. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 2 years

    Time frame: 2 years

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  52. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 3 years

    Time frame: 3 years

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  53. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 4 years

    Time frame: 4 years

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  54. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 5 years

    Time frame: 5 years

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

  55. New York Heart Association (NYHA) Functional Class at baseline

    Time frame: Baseline

    Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

  56. New York Heart Association (NYHA) Functional Class at 1 month

    Time frame: 1 month

  57. New York Heart Association (NYHA) Functional Class at 1 year

    Time frame: 1 year

  58. New York Heart Association (NYHA) Functional Class at 2 years

    Time frame: 2 years

  59. New York Heart Association (NYHA) Functional Class at 3 years

    Time frame: 3 years

  60. New York Heart Association (NYHA) Functional Class at 4 years

    Time frame: 4 years

  61. New York Heart Association (NYHA) Functional Class at 5 years

    Time frame: 5 years

  62. Six Minute Walk Test (6MWT Distance or 6MWD) at baseline

    Time frame: Baseline

    Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  63. Six Minute Walk Test (6MWT Distance or 6MWD) at 1 month

    Time frame: 1 month

  64. Six Minute Walk Test (6MWT Distance or 6MWD) at 1 year

    Time frame: 1 year

  65. Six Minute Walk Test (6MWT Distance or 6MWD) at 2 years

    Time frame: 2 years

  66. Six Minute Walk Test (6MWT Distance or 6MWD) at 3 years

    Time frame: 3 years

  67. Six Minute Walk Test (6MWT Distance or 6MWD) at 4 years

    Time frame: 4 years

  68. Six Minute Walk Test (6MWT Distance or 6MWD) at 5 years

    Time frame: 5 years

  69. Mini-Mental State Examination score at baseline

    Time frame: baseline

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  70. Mini-Mental State Examination score at 1 month

    Time frame: 1 month

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  71. Mini-Mental State Examination score at 1 year

    Time frame: 1 year

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  72. Mini-Mental State Examination score at 2 years

    Time frame: 2 years

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  73. Mini-Mental State Examination score at 3 years

    Time frame: 3 years

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  74. Mini-Mental State Examination score at 4 years

    Time frame: 4 years

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  75. Mini-Mental State Examination score at 5 years

    Time frame: 5 years

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)

  76. Modified Rankin Scale Score at baseline

    Time frame: baseline

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:

    0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  77. Modified Rankin Scale Score at 1 month

    Time frame: 1 month

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  78. Modified Rankin Scale Score at 1 year

    Time frame: 1 year

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  79. Modified Rankin Scale Score at 2 years

    Time frame: 2 years

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  80. Modified Rankin Scale Score at 3 years

    Time frame: 3 years

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  81. Modified Rankin Scale Score at 4 years

    Time frame: 4 years

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

  82. Modified Rankin Scale Score at 5 years

    Time frame: 5 years

    MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

Study contacts

Contact information is provided by the study sponsor or research team.

Jian'an Wang, PhD, MD

CONTACT

[email protected]

+86057187783777

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Central South University
  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Chinese PLA General Hospital
  • Fujian Medical University Union Hospital
  • Henan Provincial Chest Hospital
  • Ning Bo First Hospital
  • Northern Jiangsu People's Hospital
  • Second Affiliated Hospital of Nanchang University
  • Shanxi Cardiovascular Hospital
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Bengbu Medical University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Zhengzhou University
  • The Second People's Hospital of GuangDong Province
  • Tianjin Chest Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Venus MedTech (HangZhou) Inc.
  • Xiamen University Affiliated Cardiovascular Hospital

Registry information

Official study title

HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Jan 25, 2021
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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