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NCT06137807 · ClinicalTrials.gov registry record · NA
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
A NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, sponsored by P+F Products + Features USA.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06137807 is a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease that is actively recruiting participants, run by P+F Products + Features USA. The registered enrollment target is 50 participants, below the 533-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06137807, a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, is actively recruiting participants, sponsored by P+F Products + Features USA.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
Conditions Studied
Interventions
- DEVICE TricValve® Transcatheter Bicaval Valve System
Study Locations (20)
Florida
- Delray Medical Center - Delray Beach
- Largo Medical Center - Largo
- Tampa General Hospital - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Lahey Hospital & Medical Center - Burlington
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
- Tucson Medical Center - Tucson
California
- Scripps Memorial Hospital La Jolla - San Diego
- UCSF - San Francisco
Illinois
- Endeavor Health, Glenbrook Hospital - Glenview
- Chicago Advocate Christ - Palos Park
Missouri
- Saint Luke's Mid America Heart Institute - Kansas City
- Washington University St Louis - St Louis
New York
- North Shore University Hospital - Manhasset
- Montefiore Medical Center - The Bronx
Indiana
- Ascension Medical Group St. Vincent The Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2029-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06137807
The ClinicalTrials.gov registry entry for NCT06137807 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 533-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (91% lower). The listed sponsor is P+F Products + Features USA, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which TricValve® Transcatheter Bicaval Valve System is the first listed.
NCT06137807 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT06137807 about?
NCT06137807 is a clinical study titled "TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)". The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcat...
What is the current status of trial NCT06137807?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-07-23. Estimated completion is 2029-09.
What conditions does trial NCT06137807 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation, Tricuspid Valve Disease.
What interventions are being tested in trial NCT06137807?
The interventions under investigation include: TricValve® Transcatheter Bicaval Valve System (DEVICE).
Who is sponsoring clinical trial NCT06137807?
This trial is sponsored by P+F Products + Features USA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06137807 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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