Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Atrial FMR (FMR must be atrial in etiology without ventricular leaflet tethering)
Severe MR (3+ or 4+) defined as either 1) an effective regurgitant orifice area (EROA) ≥0.3 cm² or pulmonary-venous systolic flow reversal (PSVFR), or 2) in the absence of PSVFR, EROA measures 0.20-0.29 cm² with one or more of the following: regurgitant volume ≥45 mL/beat, regurgitant fraction ≥40%, or vena contracta width ≥0.5 cm.
LV ejection fraction ≥40% without more than mild regional wall motion abnormalities
Disqualifiers
Patient is clinically unstable or has been hospitalized within the prior 30 days.
Primary degenerative or organic mitral valve disease such as prolapse, Barlow's disease, rheumatic heart valve disease causing leaflet thickening, leaflet clefts or perforation, endocarditis, etc. Note: A small amount of mitral leaflet thickening or other abnormality may be present, but it cannot be the primary cause of MR.
Moderate or severe mitral annular calcification, or any degree of mitral annular calcification if it is the primary cause of the MR or would interfere with TEER.
Mitral valve area (MVA) <4.0 cm² or mean trans-mitral valve gradient >4 mmHg.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcatheter Edge-to-Edge Repair
DeviceThe intervention to be implemented in this clinical study is Transcatheter Edge-to-Edge Repair (TEER), a minimally invasive, image-guided interventional procedure specifically designed for the treatment of mitral regurgitation (MR)
Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease
DrugGuideline-Directed Medical Therapy (GDMT) for cardiovascular disease
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Device group (Interventional group)Experimental treatment 2 interventions
Group B: no Device group (Control Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first occurrence of a composite event of death from any cause, hospitalization for [worsening] heart failure or unplanned outpatient [worsening] heart failure event within 24 months
Time to first occurrence of a composite event of death from any cause, hospitalization for \[worsening\] heart failure or unplanned outpatient \[worsening\] heart failure event within 24 months * Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or \<24 hours if subject dies in the emergency room). * Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay \<24 hours. * Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
Time frame
From enrollment to the end of treatment at 24 months2
Number of participants with the primary safety endpoint (device group only)
Primary safety endpoint is the composite of the following events within 30 days * Stroke * Myocardial Infraction * Single-Leaflet Device Attachment (SLDA) * ECL-confirmed mitral stenosis requiring surgery * Any device-related complication requiring nonelective cardiovascular surgery * Durable left ventricular assist device (LVAD) implant * Heart transplantation
Time frame
From enrollment to the end of treatment at 30 daysSecondary outcomes
1
Number of participants with hospitalization for [worsening] heart failure or outpatient [worsening] heart failure events
All hospitalization for \[worsening\] heart failure or outpatient \[worsening\] heart failure events at 24 months
Time frame
From enrollment to the end of treatment at 24 months2
Number of participants with all-cause death
All-cause mortality at 24 months
Time frame
From enrollment to the end of treatment at 24 months3
Degree of MR reduction
MR reduction from baseline to 30 days, 12 months and 24 months
Time frame
From enrollment to the end of treatment at 24 months4
Rate of MR severity of 1+ or less
MR severity of 1+ or less at 30 days, 12 months and 24 months
Time frame
From enrollment to the end of treatment at 24 monthsOther outcomes
1
MR Severity Grade
The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years:
Time frame
From enrollment to the end of treatment at 5 years2
Regurgitant Volume
The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years
Time frame
From enrollment to the end of treatment at 5 years3
Regurgitant Fraction
The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years
Time frame
From enrollment to the end of treatment at 5 years4
Left Ventricle End Diastolic Volume (LVEDV)
The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years
Time frame
From enrollment to the end of treatment at 5 yearsSponsors and contacts
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Source ClinicalTrials.gov