Congenital Heart DiseaseNCT05077774
Harmony TPV Post-Approval Study
A study testing Harmony TPV System in people with Congenital Heart Disease and Tetrology of Fallot, run by Medtronic Cardiovascular at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly
- What is being tested?
- Harmony TPV System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 25 Oct 2021to Mar 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22903
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Medical City Children's Hospital
Dallas, Texas, 75230
Duke University Medical Center
Durham, North Carolina, 27710
Cedars Sinai Medical Center
Los Angeles, California, 90048
The Mount Sinai Hospital
New York, New York, 10029
Children's Hospital New York - Presbyterian
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Saint Louis Children's Hospital
St Louis, Missouri, 63110
St. Joseph Children's Hospital
Tampa, Florida, 33607
About this study
Official title: Harmony TPV Post-Approval Study (Harmony PAS2)
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.
- Being tested
- Harmony TPV System
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmony TPV SystemDevice
Also called Model Numbers: HARMONY-22, HARMONY-25, and HARMONY-DCS
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
| Study group | Role | What they receive |
|---|---|---|
| Harmony TPV System | Other | Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System Receives: Device: Harmony TPV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 6 months
Secondary outcomes (6)
Percentage of subjects free from all-cause mortality at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Percentage of subjects free from reoperation at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Percentage of subjects free from catheter reintervention at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Number and percentage of subjects with procedure success at 30-days
Measured: 30-days
Number and percentage of subjects with serious device-related adverse events at 6 months
Also described with Kaplan-Meier method for AEs of clinical interest.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start25 Oct 2021
- Primary completionNov 2026 (estimated)
- Study completionMar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Balzer, MD, Principal investigator, St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077774
- Sponsor's protocol ID
- MDT20057CON003
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37278682