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EFS of the DUO System for Tricuspid Regurgitation
NCT05913908 · View on ClinicalTrials.gov ↗
Study Summary
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
Conditions Studied
Interventions
- DEVICE DUO Transcatheter Tricuspid Coaptation Valve System
Study Locations (16)
New York
- Columbia University Medical Center/NYPH — New York
- Montefiore Medical Center — The Bronx
Arizona
- Dignity Health St. Joseph's Hospital & Medical Center — Phoenix
California
- Los Robles Hospital & Medical Center — Thousand Oaks
Georgia
- Piedmont Heart Institute — Atlanta
Illinois
- Northwestern University — Chicago
Kansas
- Ascension Via Christi Research — Wichita
Minnesota
- Allina Health Minneapolis Heart Institute Foundation — Minneapolis
Ohio
- OhioHealth Research Institute — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2029-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05913908
The ClinicalTrials.gov registry entry for NCT05913908 describes a study currently listed as 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 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CroiValve Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which DUO Transcatheter Tricuspid Coaptation Valve System 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: NCT05913908 reports 16 study locations spanning 15 distinct geographic areas — top geographies include New York, Arizona, California. 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 NCT05913908 about?
NCT05913908 is a clinical study titled "EFS of the DUO System for Tricuspid Regurgitation". The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
What is the current status of trial NCT05913908?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-08-13. Estimated completion is 2029-10.
What conditions does trial NCT05913908 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Disease, Tricuspid Valve Insufficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05913908?
The interventions under investigation include: DUO Transcatheter Tricuspid Coaptation Valve System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05913908?
This trial is sponsored by CroiValve Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05913908 being conducted?
This trial has 16 study locations across Arizona, California, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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