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Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

NCT03225612 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-02-07

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

Conditions

  • Chronic Symptomatic Functional Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Heart Valve Disease

Interventions

DEVICE

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.

Sponsors & Collaborators

  • Genae

    collaborator INDUSTRY

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • Mitralign, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. med Joachim Schofer · Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2018-06-30
Completion
2022-11-30
FDA Device
Yes

Countries

  • Germany
  • Italy
  • Netherlands
  • Portugal

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 NCT03225612 on ClinicalTrials.gov