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Harmony TPV Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05077774
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE September 30, 2021
First Posted Date  ICMJE October 14, 2021
Last Update Posted Date May 25, 2023
Actual Study Start Date  ICMJE October 25, 2021
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2022)		 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%
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2021)		 Proportion of subjects without valve intervention 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%
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2022)
  • Percentage of subjects free from all-cause mortality at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from reoperation at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from catheter reintervention at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from TPV dysfunction at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Number and percentage of subjects with procedure success at 30-days [ Time Frame: 30-days ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2021)
  • Percentage of subjects free from all-cause mortality at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from reoperation at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from catheter reintervention at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Percentage of subjects free from TPV dysfunction at 6-months [ Time Frame: 6 months ]
    Described by Kaplan-Meier statistics at 6-months.
  • Number and percentage of subjects with procedure success at 30-days [ Time Frame: 30-days ]
  • Number and percentage of subjects with serious procedure- and device-related adverse events at 6 months [ Time Frame: 6 months ]
    Also described with Kaplan-Meier method for AEs of clinical interest.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Harmony TPV Post-Approval Study
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Heart Disease
  • Tetrology of Fallot
  • RVOT Anomaly
  • Pulmonary Regurgitation
Intervention  ICMJE 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
Study Arms  ICMJE Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Intervention: Device: Harmony TPV System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2021)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2035
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Vanney 763-514-4000 RS.HarmonyPAS2@medtronic.com
Contact: Harmony Clinical Study Central Email RS.HarmonyPAS2@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05077774
Other Study ID Numbers  ICMJE MDT20057CON003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medtronic Cardiovascular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Cardiovascular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Balzer, MD St. Louis Children's Hospital
PRS Account Medtronic Cardiovascular
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP