Harmony TPV Post-Approval Study
1 other identifier
interventional
150
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
January 8, 2026
January 1, 2026
4.8 years
September 30, 2021
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of subjects free from all-cause mortality at 6-months
6 months
Percentage of subjects free from reoperation at 6-months
6 months
Percentage of subjects free from catheter reintervention at 6-months
6 months
Percentage of subjects free from TPV dysfunction at 6-months
6 months
Number and percentage of subjects with procedure success at 30-days
30-days
- +1 more secondary outcomes
Study Arms (1)
Harmony TPV System
OTHERIntervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Interventions
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
St. Joseph Children's Hospital
Tampa, Florida, 33607, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Saint Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Children's Hospital New York - Presbyterian
New York, New York, 10032, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Medical City Children's Hospital
Dallas, Texas, 75230, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (1)
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.
PMID: 37278682DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Balzer, MD
St. Louis Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 14, 2021
Study Start
October 25, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
March 1, 2035
Last Updated
January 8, 2026
Record last verified: 2026-01