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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04009434

Acronym

MITAVI

Enrollment

1162

Registered

2019-07-05

Start date

2019-12-01

Completion date

2023-08-01

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Mitral Regurgitation

Keywords

Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip, Heart Valve Diseases

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.

Interventions

DEVICEMitral Valve Clipping

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

DEVICETAVI

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Death from any cause and heart failure hospitalization	1 year	Composite endpoint of time to heart failure hospitalization or death from any cause

Secondary

Measure	Time frame	Description
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
6 Minute Walk Test	1 year	Change in 6 Minute Walk Test 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
Mitral regurgitation severity	1 year	Mitral regurgitation severity at 12 months

Other

Measure	Time frame
Number of patients with AEs, SAEs.	1, 2, 3, 4 years

Countries

Germany

Contacts

Primary ContactAxel Linke, MD

mitavi@mailbox.tu-dresden.de+49 351 4501704

Backup ContactStephan Haussig, MD