Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
2019-06 TRISCEND Study
NCT04221490 · View on ClinicalTrials.gov ↗
Study Summary
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04221490
The ClinicalTrials.gov registry entry for NCT04221490 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04221490 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04221490?
The interventions under investigation include: Transcatheter Tricuspid Valve Replacement (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04221490?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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