Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT04009434
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04009434
Study Brief:
Protocol Section:
NCT04009434