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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
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⁃ \*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.

Locations
Other Locations
China
Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen
RECRUITING
Shenzhen
Contact Information
Primary
Xiangbin Pan
panxiangbin@fuwaihospital.org
8688396666
Backup
Jianrui Ma
Jianrui0705@163.com
8688396666
Time Frame
Start Date: 2024-03-29
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 200
Treatments
Experimental: Echocardiography-guided group
Patients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance.
Active_comparator: Fluoroscopy-guided group
Patients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo.
Related Therapeutic Areas
Sponsors
Leads: Pan Xiangbin

This content was sourced from clinicaltrials.gov