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Clinical Trials in China / NCT06684171
Recruiting Not applicable

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

NCT06684171 · tracked via the Priya Life Science China tracker
Sponsor
Pan Xiangbin
Phase
Not applicable
Started
2024-03-29
Last updated
2024-11-12

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

Echocardiographic guidanceFluoroscopic guidance

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

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen Shenzhen Guangdong Recruiting

More Pan Xiangbin trials in China

Echocardiography Guided TAVR (Echo TAVR) Recruiting
A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis Recruiting
To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment Starting soon

Other trials for the same condition

TEER for Severe DMR of Low to Intermediate Surgery Risk Recruiting
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China Recruiting
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation Recruiting
The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation Recruiting
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06684171 on ClinicalTrials.gov ↗ ← All trials in China