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

Pan Xiangbin200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Interventions

Echocardiographic guidancePROCEDURE

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 guidancePROCEDURE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen

Shenzhen, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: At 30 days after device implantation

Secondary Outcomes

1-year all-cause mortality

All-cause mortality at 1 year after implantation.

Time frame: At 1 year after implantation

1-year composite of death, reintervention, and recurrent MR ≥ 3+

Composite of death, reintervention, and recurrent MR ≥ 3+ at 1 year

Time frame: At 1 year after implantation

Change in SF-36 score from baseline to 30 days and 1 year.

Change in 36-Item Short Form Survey score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.

Time frame: At 30 days and 1 year after implantation

Change in KCCQ score from baseline to 30 days and 1 year.

Change in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days and 1 year wiil be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.

Time frame: At 30 days and 1 year after implantation

Change in HADS score from baseline to 30 days and 1 year.

Change in Hospital Anxiety and Depression Scale score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an aggregation in psychological stress, while a decreased score after implantation indicates an improvement in psychological stress.

Time frame: At 30 days and 1 year after implantation

Composite of major adverse events

Composite of major adverse events immediately after implantation, at 30 days, 3 months, and at 1 year including death, myocardial infarction, reintervention, nonelective cardiovascular surgery for adverse events, ventilation over 48 hours, gastrointestinal complications requiring surgery, new-onset permanent atrial fibrillation, sepsis, and transfusion of 2 or more units of blood.

Time frame: Immediately after implantation, at 30 days, 3 months, and at 1 year

Left ventricular ejection fraction

Left ventricular ejection fraction at 30 days, 3 months, and 1 year

Time frame: At 30 days, 3 months, and 1 year after implantation

Left ventricular end-diastolic volume and left ventricular end-systolic volume

Left ventricular end-diastolic volume and left ventricular end-systolic volume at 30 days, 3 months, and 1 year after implantation.

Time frame: At 30 days, 3 months, and 1 year after implantation.

Left ventricular end-systolic diameter and left ventricular end-diastolic diameter

Left ventricular end-systolic diameter and left ventricular end-diastolic diameter at 30 days, 3 months, and 1 year after implantation

Time frame: At 30 days, 3 months, and 1 year after implantation

NYHA functional classification

At 30 days, 3 months, and 1 year after implantation.

Time frame: At 30 days, 3 months, and 1 year after implantation.

Regurgitant volume and regurgitant fraction

Regurgitant volume and regurgitant fraction at 30 days, 3 months, and 1 year.

Time frame: At 30 days, 3 months, and 1 year after implantation

Device implantation rate

Device implantation rate.

Time frame: At 30 days after device implantation

Vascular complications

Vascular complications at 30 days, 3 months, and 1 year including access-site hematoma \> 6 cm, arteriovenous fistula, symptomatic peripheral ischemia or nerve injury with symptoms or signs over 48 hours, access-site vascular injury requiring surgical repair, PE, ipsilateral DVT, access-site associated infection requiring antibiotics injection or prolonging hospital stay.

Time frame: At 30 days, 3 months, and 1 year after implantation

Major bleeding events

Major bleeding events at 30 days, 3 months, and at 1 year after implantation that is defined as any procedure-related bleeding requiring transfusion of 2 or more units of blood and/or surgical repair

Time frame: At 30 days, 3 months, and at 1 year after implantation

Arrhythmia

Arrhythmia at 30 days, and at 1 year after implantation

Time frame: At 30 days and 1 year after implantation

Infective Endocarditis

Infective Endocarditis at 30 days, 3 months, and at 1 year after implantation according to the Duke Criteria.

Time frame: At 30 days, 3 months and 1 year after implantation

Thrombotic events

Thrombotic events at 30 days, 3 months, and at 1 year after implantation.

Time frame: At 30 days, 3 months, and at 1 year after implantation

Hemolytic events

Hemolytic events at 30 days, 3 months, and at 1 year after implantation.

Time frame: At 30 days, 3 months, and at 1 year after implantation

Iatrogenic atrial septal defect

Iatrogenic ASD at 30 days, 3 months, and at 1 year after implantation.

Time frame: At 30 days, 3 months, and at 1 year after implantation.

Single leaflet device attachment

Single leaflet device attachment at 30 days, 3 months, and at 1 year after implantation.

Time frame: At 30 days, 3 months, and at 1 year after implantation.

Mitral Stenosis

Mitral stenosis at 30 days, 3 months, and at 1 year after implantation that is defined as mitral valve area \< 1.5 cm2.

Time frame: At 30 days, 3 months, and at 1 year after implantation.

Mitral valve area

Mitral valve area at 30 days, 3 months, and at 1 year after implantation.

Time frame: At 30 days, 3 months, and at 1 year after implantation.

Transmitral pressure gradient

Transmitral pressure gradient at 30 days, 3 months, and at 1 year after implantation

Time frame: At 30 days, 3 months, and at 1 year after implantation

Hospital stay after implantation

Time frame: At study completion with an average of 1 year

ICU stay after implantation

Time frame: At study completion with an average of 1 year

30-day rehospitalization for heart failure

Rehospitalization for heart failure at 30 days after implantation

Time frame: At 30 days after implantation

New Warfarin Use

New Warfarin Use at 30 days and 1 year after device Implantation

Time frame: At 30 days and 1 year after implantation

Hospital cost

Time frame: At study completion with an average of 1 year

Procedure time and radiation time

Time frame: At study completion with an average of 1 year

Central Contacts

Xiangbin Pan

CONTACT

8688396666 panxiangbin@fuwaihospital.org

Jianrui Ma

CONTACT

8688396666 Jianrui0705@163.com

Data from ClinicalTrials.gov

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