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NCT03227757 · ClinicalTrials.gov registry record · NA
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
A NA study of Tricuspid Valve Insufficiency, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT03227757: Completed NA study of Tricuspid Valve Insufficiency, sponsored by Abbott Medical Devices.
NCT03227757 is a NA study of Tricuspid Valve Insufficiency that has completed, run by Abbott Medical Devices. The registered enrollment target is 98 participants, below the 329-participant average among 6 other Tricuspid Valve Insufficiency trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03227757, a NA study of Tricuspid Valve Insufficiency, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
Primary Outcome
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Conditions Studied
Interventions
- DEVICE Tricuspid Valve Repair System
Study Locations (20)
Other
- Bichat-Claude Bernard Hospital - Paris
- Albertinen-Krankenhaus - Hamburg
- Hospital de Sant Pau - Barcelona
- Clinical and Provincial Hospital of Barcelona - Barcelona
- Inselspital Bern - Bern
- HerzKlinik Hirslanden - Klinik Hirslanden - Zurich
- University Hospital of Zurich (USZ) - Zurich
Milan
- San Raffaele University Hospital - Milan
- Istituto Clinico Sant'Ambrogio - Milan
California
- Cedars-Sinai Medical Center - Los Angeles
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- Abbott Northwestern Hospital - Minneapolis
New York
- Mount Sinai Hospital - New York
Saint-Herblain
- Hospital Nord Laennec - Chu De Nantes - Nantes
Bavaria
- Ludwig-Maximilian University of Munich (LMU) - Munich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
What the finished NCT03227757 record still lists
NCT03227757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 329-participant average among 6 other Tricuspid Valve Insufficiency trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Tricuspid Valve Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Tricuspid Valve Repair System is the first listed.
NCT03227757 names 20 study sites across 13 states, led by Other, Milan, California.
Frequently Asked Questions
What is clinical trial NCT03227757 about?
NCT03227757 is a clinical study titled "TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR". The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter in...
What is the current status of trial NCT03227757?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2017-08-01. Estimated completion is 2024-05-30.
What conditions does trial NCT03227757 study?
This clinical trial studies the following conditions: Tricuspid Valve Insufficiency.
What interventions are being tested in trial NCT03227757?
The interventions under investigation include: Tricuspid Valve Repair System (DEVICE).
Who is sponsoring clinical trial NCT03227757?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03227757 being conducted?
This trial has 20 study locations across California, Michigan, Minnesota, New York, Saint-Herblain. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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