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NCT04905017 · ClinicalTrials.gov registry record · NA
Trisol System EFS Study
A NA study of Tricuspid Regurgitation, sponsored by Trisol Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT04905017: Recruiting NA study of Tricuspid Regurgitation, sponsored by Trisol Medical.
NCT04905017 is a NA study of Tricuspid Regurgitation that is actively recruiting participants, run by Trisol Medical. The registered enrollment target is 30 participants, below the 534-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04905017, a NA study of Tricuspid Regurgitation, is actively recruiting participants, sponsored by Trisol Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study Summary
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Primary Outcome
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
Conditions Studied
Interventions
- DEVICE Transcatheter Tricuspid Valve Replacement
Study Locations (7)
California
- Cedars-Sinai Medical Center - Los Angeles
Georgia
- Piedmont Heart Institute - Atlanta
New York
- Columbia University Medical Center/NYPH - New York
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Main Line Health / Lankenau Institute for Medical Research - Wynnewood
Tennessee
- Vanderbilt University Medical Center - Nashville
Virginia
- University of Virginia Cardiology - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2031-07-01 |
| Phase | NA |
What NCT04905017 shows while recruiting
NCT04905017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 534-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Tricuspid Valve Replacement is the first listed.
NCT04905017 lists 7 locations in 7 states (California, Georgia, New York).
Frequently Asked Questions
What is clinical trial NCT04905017 about?
NCT04905017 is a clinical study titled "Trisol System EFS Study". The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
What is the current status of trial NCT04905017?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-03-02. Estimated completion is 2031-07-01.
What conditions does trial NCT04905017 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation.
What interventions are being tested in trial NCT04905017?
The interventions under investigation include: Transcatheter Tricuspid Valve Replacement (DEVICE).
Who is sponsoring clinical trial NCT04905017?
This trial is sponsored by Trisol Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04905017 being conducted?
This trial has 7 study locations across California, Georgia, New York, Ohio, Pennsylvania. 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 NCT04905017's enrollment target sits among peer trials
30 15th of 17 higher than 2 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
-
TTVR Early Feasibility Study
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-
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
RECRUITING · NA
-
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
RECRUITING · NA
-
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
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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