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Transcatheter Treatment of Tricuspid Valve Regurgitation

NCT06093828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-23

No results posted yet for this study

Summary

Tricuspid Regurgitation induces an asymmetric enlargement of the tricuspid valve (TV) annulus causing a reduction of leaflets coaptation. Annular dilation continues even after surgical treatment. The progressive nature of TR, inadequate surgical treatment, and high-risk patient population make TR an ideal target for transcatheter therapy. The TriFlo TFO System introduces a new concept for the treatment of tricuspid regurgitation. Its commissural anchoring is designed to respect TV leaflet integrity, mobility, and maintain RV contractility.

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.

Sponsors & Collaborators

  • TriFlo Cardiovascular, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-01-31
Completion
2031-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093828 on ClinicalTrials.gov