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Trisol System EFS Study

NCT04905017 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-21

No results posted yet for this study

Summary

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Transcatheter Tricuspid Valve Replacement

Replacement of the tricusupid valve using Trisol System in a transcatheter approach

Sponsors & Collaborators

  • Trisol Medical

    lead INDUSTRY

Principal Investigators

  • Isaac George, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2026-01-01
Completion
2031-07-01
FDA Device
Yes

Countries

  • United States

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 NCT04905017 on ClinicalTrials.gov