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Recruiting
NCT07321899
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
Conditions: Severe Tricuspid Regurgitation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1186
Sponsor: Medtronic Cardiovascular
Location: University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years at the time of consent.
* Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).
* Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
Exclusion Criteria:
* Any tricuspid device currently in place.
* Anatomic contraindications.
* Need for emergent or urgent surgery.
* Left ventricular ejection fraction \
Source: ClinicalTrials.gov (NCT07321899). StuddyBuddy aggregates publicly available trial information.