Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successfu… (NCT04009434) | Clinical Trial Compass
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Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Germany1,162 participantsStarted 2019-12-01
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexALL
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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…
What they're measuring
1
Death from any cause and heart failure hospitalization