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Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation

NCT05310461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-21

No results posted yet for this study

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.

Conditions

  • Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation

Interventions

PROCEDURE

Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement

Early transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.

PROCEDURE

Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention

Deferred transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Pilgrim, Prof. Dr. · Insel Gruppe AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2024-07-01
Completion
2030-01-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310461 on ClinicalTrials.gov