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Transcatheter Edge-to-Edge Repair / Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease / Atrial Functional Mitral Regurgitation · Interventional Study
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a recruiting prospective randomized controlled trial comparing transcatheter edge-to-edge repair plus guideline-directed medical therapy versus medical therapy alone in symptomatic patients with moderate-to-severe or severe atrial functional mitral regurgitation. No results are posted; the study is currently enrolling and follow-up extends to 24 months post-randomization, so no efficacy or safety data are available to assess.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Atrial Functional Mitral Regurgitation; age from 18 Years. Intervention: Device group (Interventional group). Compared with: no Device group (Control Group) — Active Comparator. n = 400. 1 site: China.
This is a registry record for a recruiting prospective randomized controlled trial comparing transcatheter edge-to-edge repair plus guideline-directed medical therapy versus medical therapy alone in symptomatic patients with moderate-to-severe or severe atrial functional mitral regurgitation. No results are posted; the study is currently enrolling and follow-up extends to 24 months post-randomization, so no efficacy or safety data are available to assess.
No outcome data, efficacy estimates, safety events, or comparative effect sizes are reported.
The source did not state who this applies to in practice.
This is a recruiting trial registration with no results posted; it describes a planned prospective randomized study of transcatheter edge-to-edge repair for atrial functional mitral regurgitation, but outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07414225). This is a study registration, not published results. Lead sponsor: Beijing Anzhen Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Atrial Functional Mitral Regurgitation. Interventions: DEVICE: Transcatheter Edge-to-Edge Repair; DRUG: Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease. Primary outcome measures: 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 , From enrollment to the end of treatment at 24 months; Number of participants with the primary safety endpoint (device group only) , From enrollment to the end of treatment at 30 days. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.