Harmony TPV Post-Approval Study

Covidien logo

Covidien

Status

Enrolling

Conditions

Tetrology of Fallot
Pulmonary Regurgitation
RVOT Anomaly
Congenital Heart Disease

Treatments

Device: Harmony TPV System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05077774
MDT20057CON003

Details and patient eligibility

About

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Enrollment

150 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
  • Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion criteria

  • Obstruction of the central veins
  • Planned concomitant branch pulmonary artery stenting at time of implant
  • Subject is pregnant at time of implant procedure
  • Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
  • A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
  • Planned implantation of the Harmony TPV in the left heart
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Pre-existing prosthetic heart valve or prosthetic ring in any position

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Harmony TPV System
Other group
Description:
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Treatment:
Device: Harmony TPV System

Trial contacts and locations

19

Loading...

Central trial contact

Harmony Clinical Study Central Email; Michelle Vanney

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems