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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 780
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: P+F Products + Features USA Inc.Updated: Aug 3, 2026Locations: 34
Eligibility criteria

Age between 18 years and 85 years old, at the time of signing the informed conse... [+7]

Patient had a recent MI, stroke, or cardiovascular accident; underwent coronary... [+35]

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Status: Recruiting

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® 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.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: P+F Products + Features USA Inc.Updated: Jun 8, 2025Locations: 36
Eligibility criteria

Subject must be 18 years or older, at the time of signing the informed consent. [+6]

Subject had a recent MI, stroke or cardiovascular accident; underwent coronary a... [+26]

Read more