Evaluating the Medtronic Harmony Transcatheter Pulmonary Valve
Harmony TPV Post-Approval Study (Harmony PAS2)
This study is testing how well the Medtronic Harmony Transcatheter Pulmonary Valve works for patients with congenital heart diseases like Tetralogy of Fallot after it’s implanted by skilled doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Medtronic Cardiovascular Industry-sponsored |
| Locations | 22 sites (Birmingham, Alabama and 21 other locations) |
| Trial ID | NCT05077774 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the functionality of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) through real-world implantation by experienced clinicians. It focuses on patients with congenital heart diseases, specifically those with Tetralogy of Fallot and related conditions. The study will gather data on the valve's performance and patient outcomes following its implantation. Eligible patients will be those who meet specific criteria for receiving the Harmony TPV.
Who should consider this trial
Good fit: Ideal candidates for this study are patients eligible for the Harmony TPV who meet the device's indications for use.
Not a fit: Patients with significant central vein obstruction or those requiring other cardiac interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options for patients with congenital heart disease by providing a less invasive valve replacement solution.
How similar studies have performed: Other studies involving transcatheter heart valves have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Birmingham, Alabama and 21 other locations
- University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States (Recruiting)
- Phoenix Children's — Phoenix, Arizona, United States (Withdrawn)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- St. Joseph Children's Hospital — Tampa, Florida, United States (Recruiting)
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States (Recruiting)
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (Withdrawn)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan Health System — Ann Arbor, Michigan, United States (Recruiting)
- Saint Louis Children's Hospital — Saint Louis, Missouri, United States (Recruiting)
- Children's Hospital & Medical Center — Omaha, Nebraska, United States (Recruiting)
- The Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Children's Hospital New York - Presbyterian — New York, New York, United States (Recruiting)
- Atrium Health Levine Children's Hospital — Charlotte, North Carolina, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Medical City Children's Hospital — Dallas, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: David Balzer, MD — St. Louis Children's Hospital
- Study coordinator: Michelle Vanney
- Email: RS.HarmonyPAS2@medtronic.com
- Phone: 763-514-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.