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NCT Number: NCT06255457

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Study objectives:

* To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery * To characterize the molecular landscape of arrhytmogenic MVP

Study design:

-Prospective explorative observational study

Study population:

-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Univeristy Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location status: Recruiting

Location contact

Bahira Shahim, MD, PhD

CONTACT

[email protected]

+46705347350

Bahira Shahim, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and over
  • Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care

Exclusion criteria

  • Secondary mitral regurgitation
  • Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)
  • Co-existing moderate or severe aortic valve disease
  • Congenital heart disease
  • Inherited or acquired cardiomyopathy
  • Non-incidental or symptomatic coronary artery disease
  • Uncontrolled atrial fibrillation (resting heart rate > 100/min)
  • Pregnancy
  • Unable to undergo CMR

Treatment and study plan

Mitral valve surgery

Procedure

Mitral valve repair or replacement of mitral regurgitation

Primary outcomes

  1. Ventricular arrhythmias

    Time frame: 6 months

    Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)

  2. Extracellular volume

    Time frame: 6 months

    Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery

Acronym: Mitra-VT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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