Congenital Heart DiseaseNCT02979587
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
A study testing Harmony TPV System in people with Congenital Heart Disease and Tetrology of Fallot, run by Medtronic Heart Valves at 12 sites in 3 countries.
Trial summary
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV. 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
- 86 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jan 2017to Feb 2031
- 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
- Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
- Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
- Subject is willing to consent to participate
Who cannot join
- Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
- RVOT anatomy or morphology that is unfavorable for device anchoring
- Positive pregnancy test
- Life expectancy of less than 1 year
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Nationwide Children's Hospital
Columbus, Ohio, 43215
Texas Children's Hospital
Houston, Texas, 77030
Ronald Regan UCLA Medical Center
Los Angeles, California, 90095
Yale University
New Haven, Connecticut, 06510
Stanford University Medical Center
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Canada2 sites
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
Read the detailed description
The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.
The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.
- 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
The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.
The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).
The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.
| Study group | Role | What they receive |
|---|---|---|
| Harmony TPV System | Other | Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems Receives: Device: Harmony TPV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Procedure- or Device-related Mortality at 30 Days.
The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
Measured: 30 days
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Defined as:
- Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-
- Pulmonary regurgitant fraction as measured by magnetic resonance imaging <20%
Measured: 6 months
Secondary outcomes (9)
Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)
Technical success at exit from catheterization lab/operating room (OR), as defined as:
- No device- or procedural-related mortality, with
- Successful access, delivery and retrieval of the delivery system, and
- Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and
- No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Measured: At exit from catheterization lab/operating room (OR)
Device Success Out to 5 Years
Device success is defined as:
- No device- or procedural-related mortality, with
- Original intended device in place, and
- No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and
- Intended performance of the device, as defined as:
- Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and
- Hemodynamic performance: Relief of insufficiency (PR < moderate) without producing the opposite (mean RVOT gradient > 40 mmHg) as measured by continuous wave Doppler, and
- Absence of para-device complications, as defined by:
- PVL = moderate, or
- Erosion, or
- RVOT or PA rupture
Measured: 5 years
Number of Participants With Procedural Success at 30 Days
Procedural success is defined as:
- Device success at 30 days, and
- None of the following device- or procedure-related serious adverse events:
- Life-threatening major bleed
- Major vascular or cardiac structural complications required unplanned reintervention or surgery
- Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)
- Pulmonary embolism
- Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support
- Prolonged intubation >48 hours
Measured: 30 days
Freedom From TPV Dysfunction Out to 5 Years
TPV dysfunction is defined as any one of the following:
- RVOT reoperation for device-related reasons
- Catheter re-intervention of TPV
- Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient >40 mmHg)
Measured: 5 years (5 year data has an anticipated reporting date of April 2026)
Assessment of Safety
All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).
Measured: Ongoing
Characterization of Quality of Life Scores Out to 5 Years
Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
Measured: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
Characterization of Right Ventricle Remodeling Following TPV Implant
Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
Measured: Baseline, 6 Month
Characterization of Quality of Life Scores Out to 5 Years
Quality of life score over time will be assessed by the SF-36 at 4 \& 5 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
Measured: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026)
Characterization of Right Ventricle Remodeling Following TPV Implant
Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
Measured: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion17 Jul 2020
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Heart Valves
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John P Cheatham, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979587
- Sponsor's protocol ID
- MDT16004CON001
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2016
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Morray BH, Gillespie MJ, Cheatham JP, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB. Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. 2025 Sep;18(9):e015196. doi: 10.1161/CIRCINTERVENTIONS.125.015196. Epub 2025 Jul 16.
PubMed 40665900Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. 2021 Apr 12;14(7):816-817. doi: 10.1016/j.jcin.2021.01.046. No abstract available.
PubMed 33826508