An interventional study of Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System and Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation, sponsored by Medtronic Cardiovascular. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Not applicable, Interventional, and Treatment
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 1,186 is above the median of 60 across 128 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid 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.
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.
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.
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.
Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.
Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.
Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement
Rate of Major Adverse Events (MAE)
Time frame: 30-days post-procedure
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
Time frame: 1-year post-procedure
Tricuspid regurgitation (TR) grade reduction
Total number of patients with at least one grade TR reduction
Time frame: 6 months post-procedure
Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life
Time frame: 6 months post-procedure
All-cause mortality
Time frame: 12 months post-procedure
Heart failure hospitalization
Time frame: 12 months post-procedure
New onset conduction disturbance (NOCD)
Time frame: 30 days post-procedure
Total procedure time
Time frame: Procedure
Right ventricle (RV) dysfunction
Time frame: 12 months post-procedure
Plan to share: No
No publications or documents are linked to this record.
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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Tricuspid Valve Insufficiency →