Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With … (NCT03242642) | Clinical Trial Compass
RecruitingNot Applicable
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
United States, Canada, Denmark1,056 participantsStarted 2017-10-23
Plain-language summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Exclusion Criteria:
* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for severe symptomatic mitral regurgitation — can you confirm my diagnosis matches that level of severity, and do you think I'd likely fit into the Primary Cohort or the MAC Cohort being studied?
2Since this trial is listed as Phase NA, which often means it's evaluating a device rather than a drug — what does that mean for how much safety and effectiveness data already exists for the Intrepid TMVR system, and how should that affect my decision?
3The procedure involves replacing the mitral valve using a catheter-based approach rather than open-heart surgery — given my overall health, do you think the risks of this transcatheter approach are lower, higher, or similar compared to conventional mitral valve surgery for someone in my situation?
4Are there standard surgical or other minimally invasive options for my mitral regurgitation that I should consider before exploring enrollment in this trial, and why might one path be better for me than the other?
5Since the trial is actively recruiting, what would the practical commitment look like for me — how many visits, how far would I need to travel, and how long would I need to be followed up after the procedure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.