Transcatheter Treatment of Tricuspid Valve Regurgitation

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

December 31, 2031

Conditions
Symptomatic Severe Tricuspid Regurgitation
Interventions
DEVICE

TriFlo Tricuspid Flow Optimizer

An introducer sheath is inserted into the femoral vein over a stiff guidewire; the sheath extends into the common iliac vein and inferior vena cava and in the right atrium. The TFO device is oriented coaxiality to the tricuspid. Once released, the delivery catheter and the steerable catheter are removed the access site closure performed by a cardiovascular or vascular surgeon or with pre-implanted percutaneous sutures per site preference.

Trial Locations (4)

20089

IRCCS Humanitas Research Hospital, Rozzano

20097

IRCCS Policlinico San Donato, San Donato Milanese

81030

Pineta Grande Hospital, Castel Volturno

00128

Policlinico Campus Biomedico, Roma

All Listed Sponsors
lead

TriFlo Cardiovascular, Inc.

INDUSTRY

NCT06093828 - Transcatheter Treatment of Tricuspid Valve Regurgitation | Biotech Hunter | Biotech Hunter