Evaluation of the Safety and Performance of Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Access in Patients with Severe Symptomatic Mitral Regurgitation
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Mitral Regurgitation
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Age: Between 18 - 110 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participant with severe symptomatic mitral regurgitation who are determined by a multidisciplinary heart team to be a candidate for bioprosthetic mitral valve replacement and are ineligible for conventional mitral valve surgery
- Anatomically suitable the Intrepid TMVR delivery system including transfemoral and transseptal access
- Participant is able to return for all required post-procedure follow-up visits
- Participants must provide written informed consent
You may not be eligible for this study if the following are true:
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- Had a transcatheter mitral valve procedure with device currently implanted
- Had prior transseptal intervention with occlusion device currently implanted
- Anatomic contraindications for Intrepid™ TMVR
- Prohibitive mitral annular calcification
- Aortic valve disease requiring intervention
- Severe tricuspid regurgitation
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents
- Contraindicated for transesophageal echocardiography (TEE)
- Need for emergent or urgent surgery
- Unwilling or unable to adhere to the protocol specified anticoagulation treatment
- History of bleeding diathesis or coagulopathy
- Active gastrointestinal (GI) bleeding
- Known hypersensitivity or contraindication to nitinol
- Any cardiac or peripheral interventional procedure performed within 30 days prior
- Has obstructive coronary artery disease requiring treatment
- Severe symptomatic carotid stenosis
- Stroke or TIA within 90 days
- Acute myocardial infarction within 90 days
- Active endocarditis or active infection requiring antibiotic therapy
- Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within 90 days
- End stage renal disease
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Pregnant
- Currently participating in an investigational drug or another device study
- Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
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