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Completed

NCT Number: NCT05002088

Portico Valve-in-Valve Retrospective Registry

The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

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Key information

Conditions

Aortic Valve Stenosis Aortic Insufficiency Aortic Stenosis Aortic Valve Disease Aortic Valve Failure Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital, Adelaide, Australia

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About this study

Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.
  • Surgical bioprosthesis true inner diameter (true ID) was ≥ 19 mm and ≤ 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing.
  • Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
  • Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection.
  • Subject is ≥ 18 years of age or legal age in host country at the time of consent.
  • Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.
  • Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system.
  • Subject had the Portico or FlexNav delivery system enter their vasculature

Exclusion criteria

  • Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
  • Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).
  • Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
  • Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
  • Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
  • Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure.
  • Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure.
  • Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis.
  • Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
  • Surgical aortic bioprosthetic valve was unstable or rocking.
  • Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.
  • Subject was unable to tolerate antiplatelet or anticoagulant therapy

Treatment and study plan

Transcatheter Aortic Valve Replacement

Device

Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement

Primary outcomes

  1. Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication.

    Time frame: 30 days post index procedure

    Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications

  2. Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.

    Time frame: 1 year post index procedure

    Composite of all-cause mortality or disabling stroke.

Secondary outcomes

  1. Number of Participants With Procedural Success

    Time frame: Procedure

    Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system

  2. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 30 days post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.

  3. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 1 year post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis.

  4. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 2 years post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

  5. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 3 years post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

  6. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 4 years post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

  7. Evaluation of Adverse Event Rates (Descriptive Endpoint)

    Time frame: 5 years post index procedure

    All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

  8. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 30 days post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  9. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 1 year post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  10. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 2 years post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  11. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 3 years post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  12. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 4 years post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  13. Assessment of Clinical Benefit Endpoint - NYHA Class

    Time frame: 5 years post index procedure

    Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years.

    The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity.

    NYHA Functional Classification

    Class I (No Limitation):

    Class II (Mild Limitation):

    Class III (Moderate Limitation):

    Class IV (Severe Limitation):

    Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

  14. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 30 Days

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  15. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 1 Year

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  16. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 2 Years

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  17. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 3 Years

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  18. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 4 Years

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  19. Paravalvular Leak as Measured by Core Lab Echocardiography

    Time frame: 5 Years

    Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

  20. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 30 days

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  21. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 1 year

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  22. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 2 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  23. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 3 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  24. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 4 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  25. Mean Transvalvular Gradient as Measured by Core Lab Echocardiography

    Time frame: 5 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  26. Aortic Valve Area as Measured by Core Lab Echocardiography

    Time frame: 30 days

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  27. Aortic Valve Area as Measured by Core Lab Echocardiography

    Time frame: 1 Year

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  28. Aortic Valve Area as Measured by Core Lab Echocardiography

    Time frame: 2 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  29. Aortic Valve Area Measured by Core Lab Echocardiography

    Time frame: 3 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  30. Aortic Valve Area as Measured by Core Lab Echocardiography

    Time frame: 4 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  31. Aortic Valve Area as Measured by Core Lab Echocardiography

    Time frame: 5 Years

    Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

  32. New Pacemaker Implant

    Time frame: 30 days

    New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.

  33. New Pacemaker Implant

    Time frame: 1 year

    New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Feb 28, 2025

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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