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NCT04221490 · ClinicalTrials.gov registry record · NA
2019-06 TRISCEND Study
A NA study of Cardiovascular Diseases and Heart Valve Diseases, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT04221490: Active NA study of Cardiovascular Diseases and Heart Valve Diseases, sponsored by Edwards Lifesciences.
NCT04221490 is a NA study of Cardiovascular Diseases and Heart Valve Diseases that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 228 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221490, a NA study of Cardiovascular Diseases and Heart Valve Diseases, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Primary Outcome
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
Conditions Studied
Interventions
- DEVICE Transcatheter Tricuspid Valve Replacement
Study Locations (20)
Other
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval) - Québec
- CHU Bordeaux, Hôpital Cardiologique Haut Lévêque - Pessac
- Clinique Pasteur - Toulouse
- InselSpital University Hospital Bern - Bern
California
- Cedars-Sinai Medical Center - Los Angeles
- Stanford University - Stanford
Georgia
- Emory University - Atlanta
- Piedmont Heart Institute - Atlanta
Massachusetts
- Massachusetts General Hospital Boston - Boston
- Brigham and Women's Hospital - Boston
New York
- Columbia University Irving Medical Center / NYPH - New York
- Montefiore Medical Center - The Bronx
Illinois
- Northwestern University - Evanston
Michigan
- Henry Ford Hospital - Detroit
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2020-05-06 |
| Est. Completion | 2029-01-31 |
| Phase | NA |
What the registry record for NCT04221490 still lists
NCT04221490 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Tricuspid Valve Replacement is the first listed.
NCT04221490 names 20 study sites across 13 states, led by Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04221490 about?
NCT04221490 is a clinical study titled "2019-06 TRISCEND Study". Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
What is the current status of trial NCT04221490?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 228 participants. The study started on 2020-05-06. Estimated completion is 2029-01-31.
What conditions does trial NCT04221490 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation.
What interventions are being tested in trial NCT04221490?
The interventions under investigation include: Transcatheter Tricuspid Valve Replacement (DEVICE).
Who is sponsoring clinical trial NCT04221490?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04221490 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
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 NCT04221490's enrollment target sits among peer trials
228 139th of 300 higher than 162 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases 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.
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