Harmony TPV Post-Approval Study

Harmony TPV Post-Approval Study (Harmony PAS2)

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 Overview

• Status: Active, not recruiting
• Conditions: Congenital Heart Disease; Pulmonary Regurgitation; Tetrology of Fallot; RVOT Anomaly
• Intervention / Treatment: Device: Harmony TPV System

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Hospital
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Florida
    • Tampa, Florida, United States, 33607
      • St. Joseph Children's Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Saint Louis Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital & Medical Center
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • New York, New York, United States, 10032
      • Children's Hospital New York - Presbyterian
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Levine Children's Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Harmony TPV System; Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System	Device: Harmony TPV System; Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS); Other Names: Model Numbers: HARMONY-22, HARMONY-25, and HARMONY-DCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:	Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND; Pulmonary regurgitant fraction as measured by CMR <20%	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects free from all-cause mortality at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Percentage of subjects free from reoperation at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Percentage of subjects free from catheter reintervention at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Percentage of subjects free from TPV dysfunction at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Number and percentage of subjects with procedure success at 30-days		30-days
Number and percentage of subjects with serious device-related adverse events at 6 months	Also described with Kaplan-Meier method for AEs of clinical interest.	6 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: David Balzer, MD, St. Louis Children's Hospital

Publications and helpful links

General Publications

• Gillespie MJ, McElhinney DB, Jones TK, Levi DS, Asnes J, Gray RG, Cabalka AK, Fujimoto K, Qureshi AM, Justino H, Bergersen L, Benson LN, Haugan D, Boe BA, Cheatham JP. 1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1917-1928. doi: 10.1016/j.jcin.2023.03.002. Epub 2023 May 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2035

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency
• Other Study ID Numbers: MDT20057CON003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes