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Heart Failure NYHA Ii Iv / Guideline-Directed Medical Therapy (GDMT) / Mitral Regurgitation Functional · Interventional Study
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned randomized controlled trial comparing mitral valve transcatheter edge-to-edge repair plus guideline-directed medical therapy versus medical therapy alone in heart failure patients with exercise-induced severe secondary mitral regurgitation. No results are reported in this registry record; the study has not yet begun recruitment.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Heart Failure - NYHA II - IV, Mitral Regurgitation Functional; age from 18 Years. Intervention: Guideline-directed medical therapy (GDMT) + mitral valve TE…. Compared with: Guideline-directed medical therapy (GDMT) — Active Comparator. n = 246. 2 sites: Germany.
This is a planned randomized controlled trial comparing mitral valve transcatheter edge-to-edge repair plus guideline-directed medical therapy versus medical therapy alone in heart failure patients with exercise-induced severe secondary mitral regurgitation. No results are reported in this registry record; the study has not yet begun recruitment.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If results demonstrate benefit, mitral valve TEER may expand treatment options for a previously underexplored phenotype of functional mitral regurgitation. Clinicians should await completion and publication of results before interpreting clinical relevance.
This is a planned randomized trial with no results reported; it represents early-phase investigation of transcatheter edge-to-edge repair in a specific phenotype (exercise-induced severe mitral regurgitation), and enrollment has not yet begun.
As stated by the source record.
Quoted from the source exactly as published.
If results demonstrate benefit, mitral valve TEER may expand treatment options for a previously underexplored phenotype of functional mitral regurgitation. Clinicians should await completion and publication of results before interpreting clinical relevance.
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 (NCT07709208). This is a study registration, not published results. Lead sponsor: Jena University Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 246 participants (ESTIMATED). Conditions: Heart Failure - NYHA II - IV, Mitral Regurgitation Functional. Interventions: OTHER: Guideline-Directed Medical Therapy (GDMT); PROCEDURE: Mitral valve TEER. Primary outcome measures: Four-step hierarchical composite primary endpoint; win ratio based on the following parameters: time to all-cause mortality at 12 months, time to first HF hospitalization, SMR progression (3+/4+) at rest, change in KCCQ score from baseline to 12 months. , 12 months. Brief summary: The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure patients with non-severe secondary mitral regurgitation (SMR) at rest and exercise-induced severe SMR. The main questions it aims to answer are: * Does mitral valve TEER in addition to GDMT lead to better overall clinical outcomes than GDMT alone in patients with heart failure and exercise-induced severe SMR? * Does mitral valve TEER reduce the risk of death, heart failure hospitalization, or worsening SMR during 12 months of follow-up compared with GDMT alone? * Does mitral valve TEER improve patients' quality of life compared with GDMT alone? Participants will: * Undergo screening assessments to confirm eligibility for the study. * Be randomly assigned to receive either GDMT alone or GDMT plus mitral valve TEER. * Attend follow-up visits at approximately 3 time points during a 12-month follow-up period. * Undergo clinical evaluations that are routinely performed in patients with heart failure and SMR, including assessment of symptoms, functional status, and cardiac function. The patients' echocardiographic data will undergo an additional centralized assessment by an independent Core Laboratory.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.