Arrhythmogenic Mitral Valve Disease in Patients Undergoing Mitral Valve Surgery

Surgery Clinical Trial

— STELLA  

Official title:

MechaniSms and ouTcomes of arrhythmogEnic mitraL vaLve diseAse in Patients Undergoing Mitral Valve Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255457
• Other study ID #: VR 2022-01472
• Secondary ID: SG-23-0142-B9870
• Status: Recruiting
• Start date: February 9, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Prolapse
• Surgery
• Ventricular Arrythmia

Intervention

Procedure:
• Mitral valve surgery
Mitral valve repair or replacement of mitral regurgitation

Locations

Country	Name	City	State
Sweden	Karolinska Univeristy Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular arrhythmias	Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)	6 months
Primary	Extracellular volume	Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR	6 months