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

NCT ID: NCT04009434

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-08-01

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.

Conditions

Aortic Stenosis; Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVI

Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy

Group Type: OTHER

TAVI

Intervention Type: DEVICE

Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.

TAVI/MitraClip

Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.

Group Type: EXPERIMENTAL

Mitral Valve Clipping

Intervention Type: DEVICE

Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.

TAVI

Intervention Type: DEVICE

Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.

Interventions

Mitral Valve Clipping

Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.

Intervention Type: DEVICE

TAVI

Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
• Moderate to severe mitral regurgitation
• Symptom status NYHA II-III
• Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
• Age ≥ 18 and < 90 years
• Written informed consent

Exclusion Criteria

• MR mechanism/anatomy precluding MitraClip therapy
• Groin blood vessels are not eligible for TAVI procedure
• Massive or torrential tricuspid regurgitation
• Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
• Life expectancy < 1 year due to non-cardiac conditions
• LVEF ≤ 25%
• Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
• Cardiomyopathy other than dilated cardiomyopathy
• Fixed pulmonary artery systolic pressure > 70 mm Hg
• Any prior mitral valve surgery or transcatheter mitral valve procedure
• Stroke or transient ischemic event within 6 months prior to randomization
• Severe symptomatic carotid stenosis
• Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
• Untreated clinically significant coronary artery disease requiring revascularization
• Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
• Need for any other cardiovascular surgery (other than MV or AV disease)
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Active endocarditis or active infections requiring current antibiotic treatment
• Any condition making it unlikely that the patient will be able to complete all protocol procedures
• Patient unable to provide written informed consent prior to study enrolment
• Pregnant or nursing women
• Women of child bearing potential
• Current participation in any other interventional clinical trial
• Patients under legal supervision or guardianship Patients placed in an institution by official or court order

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zentrum für Klinische Studien Leipzig

OTHER

Sponsor Role: collaborator

University Medical Center Mainz

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Linke, MD

Role: PRINCIPAL_INVESTIGATOR

Technische Universitaet Dresden, HEART CENTER

Locations

Heart-Center Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Axel Linke, MD

Role: CONTACT

mitavi@mailbox.tu-dresden.de

+49 351 4501704

Stephan Haussig, MD

Role: CONTACT

mitavi@mailbox.tu-dresden.de

+49 351 4501704

Facility Contacts

Stephan Haussig, MD

Role: primary

+493514501704

Other Identifiers

MITAVI

Identifier Type: -

Identifier Source: org_study_id