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Harmony TPV Post-Approval Study

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ClinicalTrials.gov Identifier: NCT05077774
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : March 15, 2023
Information provided by (Responsible Party):
Medtronic Cardiovascular

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation Device: Harmony TPV System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Harmony TPV Post-Approval Study (Harmony PAS2)
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2033

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Model Numbers: HARMONY-22, HARMONY-25, and HARMONY-DCS

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

Secondary Outcome Measures :
  1. Percentage of subjects free from all-cause mortality at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.

  2. Percentage of subjects free from reoperation at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.

  3. Percentage of subjects free from catheter reintervention at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.

  4. Percentage of subjects free from TPV dysfunction at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.

  5. Number and percentage of subjects with procedure success at 30-days [ Time Frame: 30-days ]
  6. Number and percentage of subjects with serious device-related adverse events at 6 months [ Time Frame: 6 months ]
    Also described with Kaplan-Meier method for AEs of clinical interest.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05077774

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Contact: Michelle Vanney 763-514-4000 RS.HarmonyPAS2@medtronic.com
Contact: Harmony Clinical Study Central Email RS.HarmonyPAS2@medtronic.com

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Sponsors and Collaborators
Medtronic Cardiovascular
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Principal Investigator: David Balzer, MD St. Louis Children's Hospital
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT05077774    
Other Study ID Numbers: MDT20057CON003
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023

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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
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Pulmonary Valve Insufficiency
Tetralogy of Fallot
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Valve Diseases