Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2021-10-25
2035-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Harmony TPV System
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Interventions
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Harmony TPV System
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient (or patient's legally authorized representative) is willing to consent to participate in the study
Exclusion Criteria
* 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
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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David Balzer, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis Children's Hospital
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, 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
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Saint Louis Children's Hospital
St 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
Countries
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References
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Gillespie MJ, McElhinney DB, Jones TK, Levi DS, Asnes J, Gray RG, Cabalka AK, Fujimoto K, Qureshi AM, Justino H, Bergersen L, Benson LN, Haugan D, Boe BA, Cheatham JP. 1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1917-1928. doi: 10.1016/j.jcin.2023.03.002. Epub 2023 May 17.
Other Identifiers
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MDT20057CON003
Identifier Type: -
Identifier Source: org_study_id
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