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Active, Not Recruiting

NCT Number: NCT05077774

Harmony TPV Post-Approval Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Pulmonary Regurgitation Pulmonary Valve Insufficiency RVOT Anomaly Tetralogy of Fallot Tetrology of Fallot

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Harmony TPV System

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

Harmony TPV Post-Approval Study (Harmony PAS2)

Important dates

Study start
2021
Primary completion
2026
Study completion
2035
First posted
Oct 14, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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