Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation: a Randomized Clinical Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• Moderate native aortic stenosis defined by an aortic valve area (AVA) ≤1.5 cm2 and \>1.0 cm2 and transvalvular mean gradient ≥20 mmHg and \<40 mmHg.
• Primary or secondary mitral regurgitation (at least moderate) defined by effective regurgitant orifice area (EROA) ≥20 mm2 or regurgitant volume ≥30 ml
• New York Heart Association (NYHA) functional class ≥2
Locations
Other Locations
Switzerland
Insel Gruppe AG, Inselspital Bern
RECRUITING
Bern
University Hospital Geneva (HUG)
RECRUITING
Geneva
Heart Clinic Hirslanden
RECRUITING
Zurich
Contact Information
Primary
Thomas Pilgrim, Prof. Dr.
kardio.studien@insel.ch
0041316325000
Backup
Bartowiak Joanna, Dr. med.
kardio.studien@insel.ch
0041316325000
Time Frame
Start Date: 2022-08-17
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 80
Treatments
Experimental: Early transcatheter or surgical aortic valve replacement
Early transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
Other: Control Intervention
Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention.
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern