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

Pan Xiangbin

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Procedure: Echocardiographic guidance; Procedure: Fluoroscopic guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06684171

NO.SP2024005(01)A

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. 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.*
2. FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.*
3. MV anatomy appropriate for TEER procedure.
4. Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Echocardiography-guided group

Experimental group

Description:

Patients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance.

Treatment:

Procedure: Echocardiographic guidance

Fluoroscopy-guided group

Active Comparator group

Description:

Patients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo.

Treatment:

Procedure: Fluoroscopic guidance