Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

Not Applicable

• Conditions: Mitral Regurgitation; Aortic Stenosis
• Interventions: Device: Mitral Valve Clipping; Device: TAVI

• Registration Number: NCT04009434
• Lead Sponsor: Technische Universität Dresden

Brief Summary

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Start: 2019-12-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAVI/MitraClip	TAVI	Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
TAVI	TAVI	Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
TAVI/MitraClip	Mitral Valve Clipping	Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.

Primary Outcome Measures

Name	Time	Method
Death from any cause and heart failure hospitalization	1 year	Composite endpoint of time to heart failure hospitalization or death from any cause

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk Test	1 year	Change in 6 Minute Walk Test at 12 months
Death from any cause	1, 2, 3, 4 years	Time from randomization to death from any cause
Need for mitral valve reintervention	1, 2, 3, 4 years	Need for mitral valve reintervention
Mitral regurgitation severity	1 year	Mitral regurgitation severity at 12 months
New York Heart Association Functional Class	1, 3, 6 months and 1, 2, 3, 4 years	Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years

Trial Locations

Locations (1)

Heart-Center Dresden; 🇩🇪 Dresden, Saxony, Germany