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
Results First Posted : December 2, 2021
Last Update Posted : January 30, 2023
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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 |
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.
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 : | January 2031 |

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 ]The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
- Number of Participants 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%
- Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR) [ Time Frame: 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
- Device Success Out to 5 Years [ Time Frame: 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
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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
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Absence of para-device complications, as defined by:
- PVL = moderate, or
- Erosion, or
- RVOT or PA rupture
- Number of Participants With Procedural Success at 30 Days [ Time Frame: 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
- Freedom From TPV Dysfunction Out to 5 Years [ Time Frame: 5 years (5 year data has an anticipated reporting date of April 2025) ]
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)
- Assessment of Safety [ Time Frame: Ongoing ]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: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year ]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.
- Characterization of Right Ventricle Remodeling Following TPV Implant [ Time Frame: Baseline, 6 Month ]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).
- Characterization of Quality of Life Scores Out to 5 Years [ Time Frame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2025) ]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.
- Characterization of Right Ventricle Remodeling Following TPV Implant [ Time Frame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2025) ]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).

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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 |
Documents provided by Medtronic Cardiovascular ( Medtronic Heart Valves ):
Responsible Party: | Medtronic Heart Valves |
ClinicalTrials.gov Identifier: | NCT02979587 |
Other Study ID Numbers: |
MDT16004CON001 |
First Posted: | December 1, 2016 Key Record Dates |
Results First Posted: | December 2, 2021 |
Last Update Posted: | January 30, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Heart Diseases Heart Defects, Congenital Pulmonary Valve Insufficiency Tetralogy of Fallot |
Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities Heart Valve Diseases |