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Clinical Trials in Germany / NCT06634121
Recruiting Not applicable

Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population

NCT06634121 · tracked via the Priya Life Science Germany tracker
Sponsor
LMU Klinikum
Phase
Not applicable
Started
2024-04-01
Last updated
2024-10-09

Condition(s) studied

Mitral RegurgitationValvular Heart DiseaseHeart Failure

Investigational drug(s) / intervention(s)

Transcatheter mitral valve edge-to-edge repair (M-TEER)

Transcatheter mitral valve edge-to-edge repair (M-TEER): M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.

Study summary

To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age equal or above 18 years * Written consent * Heart Team recommends M-TEER Exclusion Criteria: * Mitral Stenosis (MV mean PG \> 5 mmHg) * Cardiogenic shock or hemodynamic instability at the time of intervention * Active endocarditis * Participant in another interventional cardiology study

Primary outcome measure(s)

  • Postprocedural residual MR measured by 3D EROA — During the index procedure
    residual MR measured by 3D EROA as continuous parameter

Trial sites (1)

FacilityCityRegionStatus
LMU Klinikum Munich Bavaria Recruiting

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TRICuspid Intervention in Heart Failure Trial Active, not recruiting

Other trials for the same condition

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial Active, not recruiting
Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany Active, not recruiting
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System Active, not recruiting
Aeson TAH System - Post-Market Clinical Follow-up Study Recruiting
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06634121 on ClinicalTrials.gov ↗ ← All trials in Germany