Mitral Regurgitation
Conditions
Keywords
mitral regurgitation, transcatheter edge-to-edge repair, ECHO-CLIP, randomized clinical trail, ultrasound, echo
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.
Interventions
PROCEDUREEchocardiographic 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.
PROCEDUREFluoroscopic guidance
After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process.
Sponsors
Pan Xiangbin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombotic events | At 30 days, 3 months, and at 1 year after implantation | Thrombotic events at 30 days, 3 months, and at 1 year after implantation. |
| Hemolytic events | At 30 days, 3 months, and at 1 year after implantation | Hemolytic events at 30 days, 3 months, and at 1 year after implantation. |
| 1-year all-cause mortality | At 1 year after implantation | All-cause mortality at 1 year after implantation. |
| 1-year composite of death, reintervention, and recurrent MR ≥ 3+ | At 1 year after implantation | Composite of death, reintervention, and recurrent MR ≥ 3+ at 1 year |
| Change in SF-36 score from baseline to 30 days and 1 year. | At 30 days and 1 year after implantation | 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. |
| Change in KCCQ score from baseline to 30 days and 1 year. | At 30 days and 1 year after implantation | 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. |
| Change in HADS score from baseline to 30 days and 1 year. | At 30 days and 1 year after implantation | 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. |
| Composite of major adverse events | Immediately after implantation, at 30 days, 3 months, and at 1 year | 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. |
| Left ventricular ejection fraction | At 30 days, 3 months, and 1 year after implantation | Left ventricular ejection fraction at 30 days, 3 months, and 1 year |
| Left ventricular end-diastolic volume and left ventricular end-systolic volume | At 30 days, 3 months, and 1 year after implantation. | Left ventricular end-diastolic volume and left ventricular end-systolic volume at 30 days, 3 months, and 1 year after implantation. |
| Left ventricular end-systolic diameter and left ventricular end-diastolic diameter | At 30 days, 3 months, and 1 year after implantation | Left ventricular end-systolic diameter and left ventricular end-diastolic diameter 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 | At 30 days, 3 months, and 1 year after implantation | Regurgitant volume and regurgitant fraction at 30 days, 3 months, and 1 year. |
| Device implantation rate | At 30 days after device implantation | Device implantation rate. |
| Infective Endocarditis | At 30 days, 3 months and 1 year after implantation | Infective Endocarditis at 30 days, 3 months, and at 1 year after implantation according to the Duke Criteria. |
| Major bleeding events | At 30 days, 3 months, and at 1 year after implantation | 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 |
| Arrhythmia | At 30 days and 1 year after implantation | Arrhythmia at 30 days, and at 1 year after implantation |
| Iatrogenic atrial septal defect | At 30 days, 3 months, and at 1 year after implantation. | Iatrogenic ASD at 30 days, 3 months, and at 1 year after implantation. |
| Single leaflet device attachment | At 30 days, 3 months, and at 1 year after implantation. | Single leaflet device attachment at 30 days, 3 months, and at 1 year after implantation. |
| Mitral Stenosis | At 30 days, 3 months, and at 1 year after implantation. | Mitral stenosis at 30 days, 3 months, and at 1 year after implantation that is defined as mitral valve area \< 1.5 cm2. |
| Mitral valve area | At 30 days, 3 months, and at 1 year after implantation. | Mitral valve area at 30 days, 3 months, and at 1 year after implantation. |
| Transmitral pressure gradient | At 30 days, 3 months, and at 1 year after implantation | Transmitral pressure gradient at 30 days, 3 months, and at 1 year after implantation |
| Hospital stay after implantation | At study completion with an average of 1 year | Hospital stay after implantation |
| ICU stay after implantation | At study completion with an average of 1 year | ICU stay after implantation |
| 30-day rehospitalization for heart failure | At 30 days after implantation | Rehospitalization for heart failure at 30 days after implantation |
| New Warfarin Use | At 30 days and 1 year after implantation | New Warfarin Use at 30 days and 1 year after device Implantation |
| Hospital cost | At study completion with an average of 1 year | Hospital cost |
| Procedure time and radiation time | At study completion with an average of 1 year | Procedure time and radiation time |
| Vascular complications | At 30 days, 3 months, and 1 year after implantation | 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. |
Countries
China
Contacts
Primary ContactXiangbin Pan
Backup ContactJianrui Ma
Outcome results
None listed