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

Technische Universität Dresden

Status: Unknown

Conditions: Mitral Regurgitation; Aortic Stenosis

Treatments: Device: Mitral Valve Clipping; Device: TAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT04009434

MITAVI

Details and patient eligibility

About

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.

Enrollment: 1,162 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,162 participants in 2 patient groups

TAVI

Other group

Description:

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

Treatment:

Device: TAVI

TAVI/MitraClip

Experimental group

Description:

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

Treatment:

Device: Mitral Valve Clipping

Device: TAVI