Harmony TPV Post-Approval Study

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Brief Title

Harmony TPV Post-Approval Study

Official Title

Harmony TPV Post-Approval Study (Harmony PAS2)

Brief Summary

      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.
    



Study Type

Interventional


Primary Outcome

Proportion of subjects without valve intervention and with acceptable hemodynamic function composite at 6 months as defined by:

Secondary Outcome

 Percentage of subjects free from all-cause mortality at 6-months

Condition

Congenital Heart Disease

Intervention

Harmony TPV System

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

150

Start Date

October 25, 2021

Completion Date

May 2034

Primary Completion Date

October 2024

Eligibility Criteria

        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:

          -  Anatomy unable to accommodate a 25 Fr delivery catheter system

          -  Obstruction of the central veins

          -  Clinical or biological signs of infection including active endocarditis

          -  Planned concomitant branch pulmonary artery stenting at time of implant

          -  Positive pregnancy test at baseline (prior to CT angiography and again prior to
             implant procedure) in female subjects of childbearing potential

          -  Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically
             treated with an RV-PA conduit implant

          -  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

          -  Known allergy to aspirin, heparin, or nickel

          -  Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

          -  Pre-existing prosthetic heart valve or prosthetic ring in any position
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

David Balzer, MD, 763-514-4000, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05077774

Organization ID

MDT20057CON003


Responsible Party

Sponsor

Study Sponsor

Medtronic Cardiovascular


Study Sponsor

David Balzer, MD, Principal Investigator, St. Louis Children's Hospital


Verification Date

November 2021