Status:
UNKNOWN
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Zentrum für Klinische Studien Leipzig
University Medical Center Mainz
Conditions:
Aortic Stenosis
Mitral Regurgitation
Eligibility:
All Genders
18-89 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
1162 Patients enrolled
Trial Details
Trial ID
NCT04009434
Start Date
December 1 2019
End Date
August 1 2023
Last Update
February 5 2020
Active Locations (1)
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1
Heart-Center Dresden
Dresden, Saxony, Germany, 01307