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NCT06458907 · ClinicalTrials.gov registry record · NA
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
A NA study, sponsored by P+F Products + Features USA.
- Not yet
- Registry status
- NA
- Development phase
- 780
- Enrollment target
NCT06458907: Clinical Trial NA study, sponsored by P+F Products + Features USA.
NCT06458907 is a NA study that has not yet begun recruiting, run by P+F Products + Features USA. The registered enrollment target is 780 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06458907, a NA study, has not yet begun recruiting, sponsored by P+F Products + Features USA.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 780 participants
- Enrollment target
Study Summary
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
Primary Outcome
Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.
Interventions
- DEVICE TricValve System
- DRUG Optimal medical therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2026-08 |
| Est. Completion | 2032-11 |
| Phase | NA |
What is known before NCT06458907 opens enrollment
NCT06458907 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which TricValve System is the first listed.
NCT06458907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06458907 about?
NCT06458907 is a clinical study titled "A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.". Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
What is the current status of trial NCT06458907?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 780 participants. The study started on 2026-08. Estimated completion is 2032-11.
What interventions are being tested in trial NCT06458907?
The interventions under investigation include: TricValve System (DEVICE), Optimal medical therapy (DRUG).
Who is sponsoring clinical trial NCT06458907?
This trial is sponsored by P+F Products + Features USA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06458907's enrollment target sits among peer trials
780 141st of 2000 higher than 1,859 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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