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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Pan Xiangbin
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 30-day successful rate after device implantation (residual MR ≤2+)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Pan Xiangbin
The Vice President of Fuwai Hospital, Chinese Academy of Medical Sciences, and Director of the Structural Heart Disease Center.
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility Criteria
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 cm
- •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.
Outcomes
Primary Outcomes
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-year all-cause mortality(At 1 year after implantation)
- 1-year composite of death, reintervention, and recurrent MR ≥ 3+(At 1 year after implantation)
- Change in SF-36 score from baseline to 30 days and 1 year.(At 30 days and 1 year after implantation)
- Change in KCCQ score from baseline to 30 days and 1 year.(At 30 days and 1 year after implantation)
- Change in HADS score from baseline to 30 days and 1 year.(At 30 days and 1 year after implantation)
- Composite of major adverse events(Immediately after implantation, at 30 days, 3 months, and at 1 year)
- Left ventricular ejection fraction(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.)
- Left ventricular end-systolic diameter and left ventricular end-diastolic diameter(At 30 days, 3 months, and 1 year after implantation)
- NYHA functional classification(At 30 days, 3 months, and 1 year after implantation.)
- Regurgitant volume and regurgitant fraction(At 30 days, 3 months, and 1 year after implantation)
- Device implantation rate(At 30 days after device implantation)
- Vascular complications(At 30 days, 3 months, and 1 year after implantation)
- Major bleeding events(At 30 days, 3 months, and at 1 year after implantation)
- Arrhythmia(At 30 days and 1 year after implantation)
- Infective Endocarditis(At 30 days, 3 months and 1 year after implantation)
- Thrombotic events(At 30 days, 3 months, and at 1 year after implantation)
- Hemolytic events(At 30 days, 3 months, and at 1 year after implantation)
- Iatrogenic atrial septal defect(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.)
- Mitral Stenosis(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.)
- Transmitral pressure gradient(At 30 days, 3 months, and at 1 year after implantation)
- Hospital stay after implantation(At study completion with an average of 1 year)
- ICU stay after implantation(At study completion with an average of 1 year)
- 30-day rehospitalization for heart failure(At 30 days after implantation)
- New Warfarin Use(At 30 days and 1 year after implantation)
- Hospital cost(At study completion with an average of 1 year)
- Procedure time and radiation time(At study completion with an average of 1 year)