An interventional study of Medtronic Intrepid™ TMVR TF System in Mitral Regurgitation, sponsored by Medtronic Cardiovascular. Recruiting at 38 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Not applicable, Interventional, and Treatment
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Prospective, single-arm, multi-center, interventional, pre-market trial
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 400 is above the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medtronic Intrepid™ TMVR TF System
Device: Medtronic Intrepid™ TMVR TF System
Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System
Safety: all-cause mortality at 1-year post-procedure.
Rate of all-cause mortality at 1-year post-procedure.
Time frame: 1 year
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Time frame: 30 days
Rate of all-cause mortality (Safety).
Rate of all-cause mortality at 30 days post-procedure.
Time frame: 30 days
Disabling stroke (Safety).
Rate of disabling stroke at 30 days post-procedure.
Time frame: 30 days
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Time frame: 30 days
Reoperation or reintervention (Safety).
Rate of reoperation or reintervention at 30 days post-procedure.
Time frame: 30 days
Major access site vascular complications (Safety).
Number of major access site vascular complications at 30 days post-procedure.
Time frame: 30 days
Mitral valve regurgitation (Efficacy).
Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
Time frame: 1 year
NYHA functional class (Efficacy).
Change in NYHA functional class at 1 year (Efficacy).
Time frame: 1 year
Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).
Change of Quality of Life (QoL) at 1 year as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: 1 year
Cardiovascular hospitalizations (Efficacy).
Cardiovascular hospitalizations through 1 year (Efficacy).
Time frame: 1 year
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Aug 2029, 78 months after the start.
Of 90 industry-sponsored interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 144. This study's planned 78 months is above that.
Counting every sponsor, half of 143 studies reached it within 56 months; a quarter within 25 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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