The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02979587 |
Recruitment Status :
Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : December 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation | Device: Harmony TPV System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | July 17, 2020 |
Estimated Study Completion Date : | March 2026 |

Arm | Intervention/treatment |
---|---|
Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
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Device: Harmony TPV System
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. |
- Freedom from procedure- or device-related mortality at 30 days. [ Time Frame: 30 days ]
- Percentage of subjects with acceptable hemodynamic function composite at 6 months. [ Time Frame: 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%
- Technical success at exit from catheterization lab/operating room (OR) [ Time Frame: At exit from catheterization lab/operating room (OR) ]
- Device Success out to 5 years [ Time Frame: 5 years ]
- Procedural Success at 30 days [ Time Frame: 30 days ]
- Freedom from TPV Dysfunction out to 5 years [ Time Frame: 5 years ]
- Assessment of safety [ Time Frame: 5 years ]All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).
- Characterization of quality of life scores out to 5 years [ Time Frame: 5 years ]As assessed via the SF-36 QOL form.
- Characterization of right ventricle remodeling following TPV implant [ Time Frame: 5 years ]As assessed via cardiac magnetic resonance imaging

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979587
United States, California | |
Ronald Regan UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
Stanford University Medical Center | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06510 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 | |
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43215 | |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Primary Children's Hospital | |
Salt Lake City, Utah, United States, 84113 | |
United States, Washington | |
Seattle Children's Hospital | |
Seattle, Washington, United States, 98105 | |
Canada, Ontario | |
The Hospital for Sick Children (SickKids) | |
Toronto, Ontario, Canada, M5G 1X8 | |
Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Japan | |
National Cerebral and Cardiovascular Center | |
Suita, Osaka, Japan, 565-8565 |
Principal Investigator: | John P Cheatham, MD | Nationwide Children's Hospital |
Responsible Party: | Medtronic Heart Valves |
ClinicalTrials.gov Identifier: | NCT02979587 |
Other Study ID Numbers: |
MDT16004CON001 |
First Posted: | December 1, 2016 Key Record Dates |
Last Update Posted: | December 28, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Respiratory Insufficiency Heart Diseases Pulmonary Valve Insufficiency Tetralogy of Fallot Cardiovascular Diseases Heart Valve Diseases |
Respiration Disorders Respiratory Tract Diseases Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |