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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echocardiography-guided group | Experimental | Patients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance. |
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| Fluoroscopy-guided group | Active Comparator | Patients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic guidance | Procedure | After detailed evaluation, patients randomized in this group will undergo TEER procedure under guidance of fully echocardiography but any fluoroscopy in the entire process. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 30 days after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year all-cause mortality | All-cause mortality at 1 year after implantation. | 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 |
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Inclusion Criteria:
*Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Pan | Contact | 8688396666 | panxiangbin@fuwaihospital.org | |
| Jianrui Ma | Contact | 8688396666 | Jianrui0705@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Pan | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen | Recruiting | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576040 | Derived | Ma J, Wang C, Wang S, Fang F, Zhang F, Yan X, Tang Y, Ouyang W, Pan X, Wang C. Design and Rationale of ECHO-CLIP Study: Transcatheter Edge-to-Edge Repair for Mitral Regurgitation Under Solely Transesophageal Echocardiographic Guidance Compared With Fluoroscopic and Transesophageal Echocardiographic Coguidance. J Am Heart Assoc. 2025 Jul;14(13):e040672. doi: 10.1161/JAHA.124.040672. Epub 2025 Jun 27. |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Fluoroscopic guidance | Procedure | After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process. |
|
| 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. | 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. | 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. | 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. | 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 | 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. | 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 | At 30 days, 3 months, and 1 year after implantation |
| NYHA functional classification | At 30 days, 3 months, and 1 year after implantation. | 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. | At 30 days, 3 months, and 1 year after implantation |
| Device implantation rate | Device implantation rate. | 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. | 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 | At 30 days, 3 months, and at 1 year after implantation |
| Arrhythmia | Arrhythmia at 30 days, and at 1 year after implantation | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | At 30 days, 3 months, and at 1 year after implantation |
| Hospital stay after implantation | Hospital stay after implantation | At study completion with an average of 1 year |
| ICU stay after implantation | ICU stay after implantation | At study completion with an average of 1 year |
| 30-day rehospitalization for heart failure | Rehospitalization for heart failure at 30 days after implantation | At 30 days after implantation |
| New Warfarin Use | New Warfarin Use at 30 days and 1 year after device Implantation | At 30 days and 1 year after implantation |
| Hospital cost | Hospital cost | At study completion with an average of 1 year |
| Procedure time and radiation time | Procedure time and radiation time | At study completion with an average of 1 year |