Clinical trial NCT06684171: Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: mitral regurgitation
transcatheter edge-to-edge repair
ECHO-CLIP
randomized clinical trail
ultrasound
echo
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: 30-day successful rate after device implantation (residual MR ≤2+)
timeFrame: At 30 days after device implantation
Secondary outcomes:
measure: 1-year all-cause mortality
timeFrame: At 1 year after implantation
measure: 1-year composite of death, reintervention, and recurrent MR ≥ 3+
timeFrame: At 1 year after implantation
measure: Change in SF-36 score from baseline to 30 days and 1 year.
timeFrame: At 30 days and 1 year after implantation
measure: Change in KCCQ score from baseline to 30 days and 1 year.
timeFrame: At 30 days and 1 year after implantation
measure: Change in HADS score from baseline to 30 days and 1 year.
timeFrame: At 30 days and 1 year after implantation
measure: Composite of major adverse events
timeFrame: Immediately after implantation, at 30 days, 3 months, and at 1 year
measure: Left ventricular ejection fraction
timeFrame: At 30 days, 3 months, and 1 year after implantation
measure: Left ventricular end-diastolic volume and left ventricular end-systolic volume
timeFrame: At 30 days, 3 months, and 1 year after implantation.
measure: Left ventricular end-systolic diameter and left ventricular end-diastolic diameter
timeFrame: At 30 days, 3 months, and 1 year after implantation
measure: NYHA functional classification
timeFrame: At 30 days, 3 months, and 1 year after implantation.
measure: Regurgitant volume and regurgitant fraction
timeFrame: At 30 days, 3 months, and 1 year after implantation
measure: Device implantation rate
timeFrame: At 30 days after device implantation
measure: Vascular complications
timeFrame: At 30 days, 3 months, and 1 year after implantation
measure: Major bleeding events
timeFrame: At 30 days, 3 months, and at 1 year after implantation
measure: Arrhythmia
timeFrame: At 30 days and 1 year after implantation
measure: Infective Endocarditis
timeFrame: At 30 days, 3 months and 1 year after implantation
measure: Thrombotic events
timeFrame: At 30 days, 3 months, and at 1 year after implantation
measure: Hemolytic events
timeFrame: At 30 days, 3 months, and at 1 year after implantation
measure: Iatrogenic atrial septal defect
timeFrame: At 30 days, 3 months, and at 1 year after implantation.
measure: Single leaflet device attachment
timeFrame: At 30 days, 3 months, and at 1 year after implantation.
measure: Mitral Stenosis
timeFrame: At 30 days, 3 months, and at 1 year after implantation.
measure: Mitral valve area
timeFrame: At 30 days, 3 months, and at 1 year after implantation.
measure: Transmitral pressure gradient
timeFrame: At 30 days, 3 months, and at 1 year after implantation
measure: Hospital stay after implantation
timeFrame: At study completion with an average of 1 year
measure: ICU stay after implantation
timeFrame: At study completion with an average of 1 year
measure: 30-day rehospitalization for heart failure
timeFrame: At 30 days after implantation
measure: New Warfarin Use
timeFrame: At 30 days and 1 year after implantation
measure: Hospital cost
timeFrame: At study completion with an average of 1 year
measure: Procedure time and radiation time
timeFrame: At study completion with an average of 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen
state: Guangdong
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan
role: PRINCIPAL_INVESTIGATOR
References: