The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
- Conditions
- Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation
- Interventions
- Device: Harmony TPV System
- Registration Number
- NCT02979587
- Lead Sponsor
- Medtronic Heart Valves
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Harmony TPV System Harmony TPV System Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
- Primary Outcome Measures
Name Time Method Freedom From Procedure- or Device-related Mortality at 30 Days. 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 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%
- Secondary Outcome Measures
Name Time Method Device Success Out to 5 Years 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 ruptureNumber of Participants With Procedural Success at 30 Days 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 hoursCharacterization of Right Ventricle Remodeling Following TPV Implant 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).
Assessment of Safety 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 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.
Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR) 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 procedureFreedom From TPV Dysfunction Out to 5 Years 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)
Trial Locations
- Locations (12)
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Yale University
🇺🇸New Haven, Connecticut, United States
Ronald Regan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
National Cerebral and Cardiovascular Center
🇯🇵Suita, Osaka, Japan
Mayo Clinic
🇺🇸Rochester, Minnesota, United States