Harmony TPV Post-Approval Study
- Conditions
- Congenital Heart DiseaseTetrology of FallotPulmonary RegurgitationRVOT Anomaly
- Interventions
- Device: Harmony TPV System
- Registration Number
- NCT05077774
- Lead Sponsor
- Medtronic Cardiovascular
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
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 System
- Primary Outcome Measures
Name Time Method Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: 6 months * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND
* Pulmonary regurgitant fraction as measured by CMR \<20%
- Secondary Outcome Measures
Name Time Method Percentage of subjects free from catheter reintervention at 6-months 6 months Described by Kaplan-Meier statistics at 6-months.
Number and percentage of subjects with serious device-related adverse events at 6 months 6 months Also described with Kaplan-Meier method for AEs of clinical interest.
Percentage of subjects free from all-cause mortality at 6-months 6 months Described by Kaplan-Meier statistics at 6-months.
Percentage of subjects free from TPV dysfunction at 6-months 6 months Described by Kaplan-Meier statistics at 6-months.
Number and percentage of subjects with procedure success at 30-days 30-days Percentage of subjects free from reoperation at 6-months 6 months Described by Kaplan-Meier statistics at 6-months.
Trial Locations
- Locations (22)
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Phoenix Children's
🇺🇸Phoenix, Arizona, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
St. Joseph Children's Hospital
🇺🇸Tampa, Florida, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Saint Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital & Medical Center
🇺🇸Omaha, Nebraska, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Children's Hospital New York - Presbyterian
🇺🇸New York, New York, United States
Atrium Health Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical City Children's Hospital
🇺🇸Dallas, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada