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Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation

NCT07709208 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Heart Failure - NYHA II - IV
  • Mitral Regurgitation Functional

Interventions

OTHER

Guideline-Directed Medical Therapy (GDMT)

Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines. Medical treatment may include optimized pharmacological therapy such as beta-blockers, ACE inhibitors/ARBs/ARNI, mineralocorticoid receptor antagonists, diuretics, SGLT2-inhibitors and other indicated medications. Treatment is adjusted based on clinical status and treating physician judgment.

PROCEDURE

Mitral valve TEER

Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines in combination with TEER of the mitral valve using the PASCAL Precision system (Edwards Lifesciences Sàrl). The procedure is performed via a minimally invasive transcatheter approach through femoral venous access to reduce SMR. Guideline-directed medical therapy is continued and optimized throughout follow-up according to standard of care.

Sponsors & Collaborators

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Christian Schulze, Prof. Dr. · University Hospital Jena

  • Maximilian Spieker, PD Dr. · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-06-30
Completion
2030-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709208 on ClinicalTrials.gov