The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

September 9, 2025 updated by: Medtronic Heart Valves
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.

The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children (SickKids)
  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • National Cerebral and Cardiovascular Center
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Regan UCLA Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
  • Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
  • Subject is willing to consent to participate

Exclusion Criteria:

  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
  • RVOT anatomy or morphology that is unfavorable for device anchoring
  • Positive pregnancy test
  • Life expectancy of less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
Device: Harmony TPV System

The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.

The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).

The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Procedure- or Device-related Mortality at 30 Days.
Time Frame: 30 days
The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
30 days
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Time Frame: 6 months

Defined as:

  • Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-
  • Pulmonary regurgitant fraction as measured by magnetic resonance imaging <20%
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)
Time Frame: At exit from catheterization lab/operating room (OR)

Technical success at exit from catheterization lab/operating room (OR), as defined as:

  • No device- or procedural-related mortality, with
  • Successful access, delivery and retrieval of the delivery system, and
  • Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and
  • No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
At exit from catheterization lab/operating room (OR)
Device Success Out to 5 Years
Time Frame: 5 years

Device success is defined as:

  • No device- or procedural-related mortality, with
  • Original intended device in place, and
  • No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and

  • Intended performance of the device, as defined as:

    • Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and
    • Hemodynamic performance: Relief of insufficiency (PR < moderate) without producing the opposite (mean RVOT gradient > 40 mmHg) as measured by continuous wave Doppler, and

  • Absence of para-device complications, as defined by:

    • PVL = moderate, or
    • Erosion, or
    • RVOT or PA rupture
5 years
Number of Participants With Procedural Success at 30 Days
Time Frame: 30 days

Procedural success is defined as:

  • Device success at 30 days, and

  • None of the following device- or procedure-related serious adverse events:

    • Life-threatening major bleed
    • Major vascular or cardiac structural complications required unplanned reintervention or surgery
    • Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)
    • Pulmonary embolism
    • Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support
    • Prolonged intubation >48 hours
30 days
Assessment of Safety
Time Frame: Ongoing
All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).
Ongoing
Characterization of Quality of Life Scores Out to 5 Years
Time Frame: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
Characterization of Right Ventricle Remodeling Following TPV Implant
Time Frame: Baseline, 6 Month
Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
Baseline, 6 Month
Freedom From TPV Dysfunction Out to 5 Years
Time Frame: 5 years (5 year data has an anticipated reporting date of April 2026)

TPV dysfunction is defined as any one of the following:

  • RVOT reoperation for device-related reasons
  • Catheter re-intervention of TPV
  • Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient >40 mmHg)
5 years (5 year data has an anticipated reporting date of April 2026)
Characterization of Quality of Life Scores Out to 5 Years
Time Frame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026)
Quality of life score over time will be assessed by the SF-36 at 4 & 5 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026)
Characterization of Right Ventricle Remodeling Following TPV Implant
Time Frame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026)
Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Heart Valves

Investigators

  • Principal Investigator: John P Cheatham, MD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 17, 2020

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimated)

December 1, 2016

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT16004CON001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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