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Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.

NCT02574650 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-27

No results posted yet for this study

Summary

The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).

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) delivered by a percutaneous transcatheter procedure.

Sponsors & Collaborators

  • Mitralign, Inc.

    lead INDUSTRY

Principal Investigators

  • Rebecca Hahn, MD · Columbia Unviersity Medical Center / New York-Presbyterian Hospital

  • Christopher Meduri, MD, MPH · Piedmont Healthcare

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
2015-11-30
Primary Completion
2018-05-31
Completion
2019-05-31

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 NCT02574650 on ClinicalTrials.gov