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TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device

NCT04141137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-04-20

No results posted yet for this study

Summary

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

Conditions

  • Severe Tricuspid Regurgitation

Interventions

DEVICE

TricValve® System

The TricValve® Delivery System (catheter) with already pre-mounted biological heart valve is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is released at the implantation site and positions itself as per the anatomy - self expanding frame.

Sponsors & Collaborators

  • P+F Products + Features GmbH

    lead INDUSTRY

Principal Investigators

  • Alexander Lauten, Prof.Dr.med. · Charite University, Berlin, Germany

  • Iniguez Romo Andrés, Dr. · Hospital Universitario Alvaro Cunqueiro- Vigo

  • Christian Hengstenberg, UnivProf.Dr. · Medical University of Vienna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2021-05-05
Completion
2021-12-02

Countries

  • Austria
  • Spain

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 NCT04141137 on ClinicalTrials.gov