Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04913727

Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-10-18

300

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

U

University Hospital, Basel, Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.

CONDITIONS

Official Title

Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe secondary mitral regurgitation defined by regurgitant volume 230 mL/beat or effective regurgitant orifice 20 mm
  • Symptomatic patients with New York Heart Association Class II or higher
  • Left ventricular ejection fraction between 15% and 50%
  • Receiving optimal standard heart failure care as determined by investigator
  • Not eligible for mitral surgery intervention according to Heart Team
  • Able to understand study requirements and provide written consent
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Pregnant or breastfeeding
  • Severe kidney function impairment with GFR less than 15 ml/min
  • Untreated severe other valve diseases such as severe tricuspid regurgitation or aortic stenosis
  • Medical conditions or serious illnesses that reduce ability to comply with study and follow-up
  • Contraindications to CMR including certain metallic implants, pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, infusion pumps, or severe claustrophobia
  • Clinically unstable or stage D congestive heart failure or unable to lie flat for 60 minutes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Cardiology, University Hospital Bern, Inselspital, Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

C

Christoph MD Gräni, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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