Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System.
- Who it may be relevant to
- Registry conditions: Severe Tricuspid Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER
Overview
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.
Detailed description
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.
Interventions
- Device Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement - Device Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Tricuspid regurgitation (TR) grade reduction [Time frame: 6 months post-procedure]
- Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline [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]
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 <25%.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Abrazo Arizona Heart Hospital — Phoenix
- Los Robles Hospital & Medical Center — Thousand Oaks
- Abbott Northwestern Hospital — Minneapolis
- The Christ Hospital — Cincinnati
Identifiers
NCT: NCT07321899 · MDT23032TMV006