Clinical trial NCT04009434: Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Official title: Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Zentrum für Klinische Studien Leipzig
name: University Medical Center Mainz
First posted: 2019-07-05
Enrollment: 1162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Death from any cause and heart failure hospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Death from any cause
timeFrame: 1, 2, 3, 4 years
measure: Need for mitral valve reintervention
timeFrame: 1, 2, 3, 4 years
measure: Mitral regurgitation severity
timeFrame: 1 year
measure: 6 Minute Walk Test
timeFrame: 1 year
measure: New York Heart Association Functional Class
timeFrame: 1, 3, 6 months and 1, 2, 3, 4 years
Other outcomes:
measure: Number of patients with AEs, SAEs.
timeFrame: 1, 2, 3, 4 years
Locations:
city: Dresden
country: Germany
facility: Heart-Center Dresden
state: Saxony
Study officials:
affiliation: Technische Universitaet Dresden, HEART CENTER
name: Axel Linke, MD
role: PRINCIPAL_INVESTIGATOR
References: