← Back to all trials
Not Yet Recruiting
NCT07709208
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Conditions: Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 246
Sponsor: Jena University Hospital
Location: Department of Cardiology, Pneumology and Vascular Medicine University Hospital Düsseldorf Düsseldorf
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.
Eligibility Criteria
Inclusion Criteria:
* Mild-to-moderate (1+/2+) SMR at rest
* Exacerbation of SMR to exercise-induced severe (3+/4+) SMR defined by at least one of the following:
* 40 mm\^2 EROA (30 mm\^2 under low-flow condition) or
* regurgitant volume ≥60 mL (45 mL under low-flow condition) or
* regurgitant fraction ≥40% or
* increase by 13 mm\^2 EROA from rest to exercise
* Increase in natriuretic peptides defined as NT-proBNP:
* \>250 pg/ml (Sinus rhythm) or
* \>600 pg/ml (Atrial fibrillation) or
* HF hospitalization within 12 months prior to screening (defined as HF listed as the major reason for hospitalization)
* NYHA class II-IV
* Stable HF medication regimen (GDMT) for at least 30 days prior to index procedure
* Patient deemed appropriate candidate for TEER by the local multidisciplinary heart team
* Age ≥ 18 years old
* Written Informed consent
Exclusion Criteria:
* Hospitalization in past three months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
* LVEDD \>70 mm
* LVEF \
Source: ClinicalTrials.gov (NCT07709208). StuddyBuddy aggregates publicly available trial information.