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NCT Number: NCT06684171

Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)

Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated. Transcatheter edge-to-edge repair (TEER) has recently emerged as a popular strategy due to minimal invasiveness. What's more, previous studies, such as EVEREST II and COAPT study, have demonstrated its efficacy in high-risk patients with primary or secondary MR. Conventional TEER procedure, however, is performed under combined guidance of both echocardiography and fluoroscopy, which potentially results in high radiation exposure and limits its application. Since 2021 2021, the investigators have changed the procedural methodology by performing TEER under full echocardiographic guidance on accumulated dozens of MR patients successfully. To confirm the efficacy of a fully echo-guided TEER procedure, the investigators conduct the ECHO-CLIP study to compare its outcomes with the conventional TEER procedure, as well as evaluate the outcomes of this novel methodology in special populations with radiation contraindications. ECHO-CLIP study is a prospective, multicenter, open-label, noninferior, randomized controlled trial of TEER by two different methodological strategies in treating severe primary or secondary MR. It is anticipated to enroll a total of 200 patients as well to complete the enrollment before Dec 31, 2025 and the follow-up before Dec 31, 2026. This work will potentially demonstrate the feasibility and efficacy of the fully echo-guided TEER procedure, thereby revolutionizing the TEER methodology and benefiting more patients.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen

Shenzhen, Guangdong, 518000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

*Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.

  • Symptomatic DMR subjects with MR ≥ 3+ at high surgical risk in terms of STS Predicted Risk of Mortality replacement score ≥ 8 or STS Predicted Risk of Mortality repair score ≥ 6.*
  • FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.*
  • MV anatomy appropriate for TEER procedure.
  • Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.

Exclusion criteria

  • Myocardial infarction within 12 weeks prior to randomization.
  • Need for concurrent other cardiac procedures.
  • Any endovascular intervention or surgery within 30 days prior to randomization.
  • LVEF < 20%.
  • MV orifice area < 4.0 cm2.
  • Pulmonary artery systolic pressure > 70 mmHg, as determined by echocardiogram.
  • Severe mitral annular calcification.
  • Unsuitable MV anatomy potentially precluding clip implantation: leaflet calcification or significant leaflet cleft in the grasping zone.
  • Previous MV surgery or current implanted ventricular assist device or current implanted mechanical prosthetic valve.
  • Any intracardiac mass, thrombus, or vegetation, as evidenced by echocardiogram.
  • Active endocarditis or rheumatic heart disease.
  • History of DVT or PE.

Abbreviations: DMR, degenerative mitral regurgitation; MR, mitral regurgitation; STS, Society of Thoracic Surgeons; FMR, functional mitral regurgitation; LVESD, left ventricular end-systolic diameter; GDMT, guideline-directed medical therapy; TEER, transcatheter edge-to-edge repair; LVEF, left ventricular ejection fraction; MV, mitral valve; DVT, deep venous thrombosis; PE, pulmonary embolism.

Treatment and study plan

Echocardiographic guidance

Procedure

After detailed evaluation, patients randomized in this group will undergo TEER procedure under guidance of fully echocardiography but any fluoroscopy in the entire process.

Fluoroscopic guidance

Procedure

After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process.

Primary outcomes

  1. 30-day successful rate after device implantation (residual MR ≤2+)

    Time frame: At 30 days after device implantation

    The primary outcome is the success rate of device implantation at 30 days ( residual MR≤moderate). Evaluation of the primary endpoints was done by specialized sonographers blinded to the intervention.

Secondary outcomes

  1. 1-year all-cause mortality

    Time frame: At 1 year after implantation

    All-cause mortality at 1 year after implantation.

  2. 1-year composite of death, reintervention, and recurrent MR ≥ 3+

    Time frame: At 1 year after implantation

    Composite of death, reintervention, and recurrent MR ≥ 3+ at 1 year

  3. Change in SF-36 score from baseline to 30 days and 1 year.

    Time frame: At 30 days and 1 year after implantation

    Change in 36-Item Short Form Survey score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.

  4. Change in KCCQ score from baseline to 30 days and 1 year.

    Time frame: At 30 days and 1 year after implantation

    Change in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days and 1 year wiil be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.

  5. Change in HADS score from baseline to 30 days and 1 year.

    Time frame: At 30 days and 1 year after implantation

    Change in Hospital Anxiety and Depression Scale score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an aggregation in psychological stress, while a decreased score after implantation indicates an improvement in psychological stress.

  6. Composite of major adverse events

    Time frame: Immediately after implantation, at 30 days, 3 months, and at 1 year

    Composite of major adverse events immediately after implantation, at 30 days, 3 months, and at 1 year including death, myocardial infarction, reintervention, nonelective cardiovascular surgery for adverse events, ventilation over 48 hours, gastrointestinal complications requiring surgery, new-onset permanent atrial fibrillation, sepsis, and transfusion of 2 or more units of blood.

  7. Left ventricular ejection fraction

    Time frame: At 30 days, 3 months, and 1 year after implantation

    Left ventricular ejection fraction at 30 days, 3 months, and 1 year

  8. Left ventricular end-diastolic volume and left ventricular end-systolic volume

    Time frame: At 30 days, 3 months, and 1 year after implantation.

    Left ventricular end-diastolic volume and left ventricular end-systolic volume at 30 days, 3 months, and 1 year after implantation.

  9. Left ventricular end-systolic diameter and left ventricular end-diastolic diameter

    Time frame: At 30 days, 3 months, and 1 year after implantation

    Left ventricular end-systolic diameter and left ventricular end-diastolic diameter at 30 days, 3 months, and 1 year after implantation

  10. NYHA functional classification

    Time frame: At 30 days, 3 months, and 1 year after implantation.

    At 30 days, 3 months, and 1 year after implantation.

  11. Regurgitant volume and regurgitant fraction

    Time frame: At 30 days, 3 months, and 1 year after implantation

    Regurgitant volume and regurgitant fraction at 30 days, 3 months, and 1 year.

  12. Device implantation rate

    Time frame: At 30 days after device implantation

    Device implantation rate.

  13. Vascular complications

    Time frame: At 30 days, 3 months, and 1 year after implantation

    Vascular complications at 30 days, 3 months, and 1 year including access-site hematoma > 6 cm, arteriovenous fistula, symptomatic peripheral ischemia or nerve injury with symptoms or signs over 48 hours, access-site vascular injury requiring surgical repair, PE, ipsilateral DVT, access-site associated infection requiring antibiotics injection or prolonging hospital stay.

  14. Major bleeding events

    Time frame: At 30 days, 3 months, and at 1 year after implantation

    Major bleeding events at 30 days, 3 months, and at 1 year after implantation that is defined as any procedure-related bleeding requiring transfusion of 2 or more units of blood and/or surgical repair

  15. Arrhythmia

    Time frame: At 30 days and 1 year after implantation

    Arrhythmia at 30 days, and at 1 year after implantation

  16. Infective Endocarditis

    Time frame: At 30 days, 3 months and 1 year after implantation

    Infective Endocarditis at 30 days, 3 months, and at 1 year after implantation according to the Duke Criteria.

  17. Thrombotic events

    Time frame: At 30 days, 3 months, and at 1 year after implantation

    Thrombotic events at 30 days, 3 months, and at 1 year after implantation.

  18. Hemolytic events

    Time frame: At 30 days, 3 months, and at 1 year after implantation

    Hemolytic events at 30 days, 3 months, and at 1 year after implantation.

  19. Iatrogenic atrial septal defect

    Time frame: At 30 days, 3 months, and at 1 year after implantation.

    Iatrogenic ASD at 30 days, 3 months, and at 1 year after implantation.

  20. Single leaflet device attachment

    Time frame: At 30 days, 3 months, and at 1 year after implantation.

    Single leaflet device attachment at 30 days, 3 months, and at 1 year after implantation.

  21. Mitral Stenosis

    Time frame: At 30 days, 3 months, and at 1 year after implantation.

    Mitral stenosis at 30 days, 3 months, and at 1 year after implantation that is defined as mitral valve area < 1.5 cm2.

  22. Mitral valve area

    Time frame: At 30 days, 3 months, and at 1 year after implantation.

    Mitral valve area at 30 days, 3 months, and at 1 year after implantation.

  23. Transmitral pressure gradient

    Time frame: At 30 days, 3 months, and at 1 year after implantation

    Transmitral pressure gradient at 30 days, 3 months, and at 1 year after implantation

  24. Hospital stay after implantation

    Time frame: At study completion with an average of 1 year

    Hospital stay after implantation

  25. ICU stay after implantation

    Time frame: At study completion with an average of 1 year

    ICU stay after implantation

  26. 30-day rehospitalization for heart failure

    Time frame: At 30 days after implantation

    Rehospitalization for heart failure at 30 days after implantation

  27. New Warfarin Use

    Time frame: At 30 days and 1 year after implantation

    New Warfarin Use at 30 days and 1 year after device Implantation

  28. Hospital cost

    Time frame: At study completion with an average of 1 year

    Hospital cost

  29. Procedure time and radiation time

    Time frame: At study completion with an average of 1 year

    Procedure time and radiation time

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Pan Xiangbin

Other

Registry information

Official study title

A Randomized Clinical Trial of Transcatheter Edge-to-edge Repair for Mitral Regurgitation Under Fully Echocardiographic Guidance Compared with Under Combined Guidance of Both Echocardiography and Fluoroscopy (ECHO-CLIP Study)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

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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