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NCT04433065 · ClinicalTrials.gov registry record · NA
TTVR Early Feasibility Study
A NA study of Tricuspid Regurgitation, sponsored by Medtronic Cardiovascular.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04433065: Recruiting NA study of Tricuspid Regurgitation, sponsored by Medtronic Cardiovascular.
NCT04433065 is a NA study of Tricuspid Regurgitation that is actively recruiting participants, run by Medtronic Cardiovascular. The registered enrollment target is 150 participants, below the 527-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04433065, a NA study of Tricuspid Regurgitation, is actively recruiting participants, sponsored by Medtronic Cardiovascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Primary Outcome
Rate of implant or delivery related serious adverse events
Conditions Studied
Interventions
- DEVICE Intrepid™ TTVR System
Study Locations (20)
New York
- The Mount Sinai Hospital - New York
- New York-Presbyterian Hospital Columbia University Medical Center - New York
- Montefiore Medical Center - The Bronx
Ohio
- The Christ Hospital - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
- OhioHealth Riverside Methodist Hospital - Columbus
California
- Cedars Sinai Medical Center - Los Angeles
- California Pacific Medical Center - San Francisco
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
- Corewell Health - Grand Rapids
Alabama
- University of Alabama at Birmingham (UAB) Hospital - Birmingham
Arizona
- Abrazo Arizona Heart Hospital - Phoenix
Connecticut
- Hartford Hospital - Hartford
Georgia
- Emory University Hospital Midtown - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2031-07-30 |
| Phase | NA |
What NCT04433065 shows while recruiting
NCT04433065 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 527-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Intrepid™ TTVR System is the first listed.
NCT04433065 names 20 study sites across 14 states, led by New York, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT04433065 about?
NCT04433065 is a clinical study titled "TTVR Early Feasibility Study". The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
What is the current status of trial NCT04433065?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-10-20. Estimated completion is 2031-07-30.
What conditions does trial NCT04433065 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation.
What interventions are being tested in trial NCT04433065?
The interventions under investigation include: Intrepid™ TTVR System (DEVICE).
Who is sponsoring clinical trial NCT04433065?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04433065 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tricuspid Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04433065's enrollment target sits among peer trials
150 9th of 17 higher than 9 of 17 other Tricuspid Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tricuspid Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
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-
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
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-
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
RECRUITING · NA
-
Trisol System EFS Study
RECRUITING · NA
-
EFS of the DUO System for Tricuspid Regurgitation
RECRUITING · NA
-
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
RECRUITING · NA
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