Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05077774 · ClinicalTrials.gov registry record · NA
Harmony TPV Post-Approval Study
A NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05077774: Active NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Cardiovascular.
NCT05077774 is a NA study of Congenital Heart Disease and Pulmonary Regurgitation that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 150 participants, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05077774, a NA study of Congenital Heart Disease and Pulmonary Regurgitation, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%
Conditions Studied
Interventions
- DEVICE Harmony TPV System
Study Locations (20)
New York
- The Mount Sinai Hospital - New York
- Children's Hospital New York - Presbyterian - New York
North Carolina
- Atrium Health Levine Children's Hospital - Charlotte
- Duke University Medical Center - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
California
- Cedars Sinai Medical Center - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Florida
- St. Joseph Children's Hospital - Tampa
Illinois
- Advocate Christ Medical Center - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2035-03 |
| Phase | NA |
What the registry record for NCT05077774 still lists
NCT05077774 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Harmony TPV System is the first listed.
NCT05077774 names 20 study sites across 17 states, led by New York, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05077774 about?
NCT05077774 is a clinical study titled "Harmony TPV Post-Approval Study". 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.
What is the current status of trial NCT05077774?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-10-25. Estimated completion is 2035-03.
What conditions does trial NCT05077774 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Pulmonary Regurgitation, Tetrology of Fallot, RVOT Anomaly.
What interventions are being tested in trial NCT05077774?
The interventions under investigation include: Harmony TPV System (DEVICE).
Who is sponsoring clinical trial NCT05077774?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077774 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05077774's enrollment target sits among peer trials
150 24th of 63 higher than 39 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Fontan Fitness Trial
RECRUITING · NA
-
Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
RECRUITING · NA
-
The Sequencing for Detection in Congenital Heart Disease (SD-CHD) Study
RECRUITING · NA
-
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
RECRUITING · NA
-
A Study of Hemodynamic Cardiopulmonary Exercise for CHD
RECRUITING · NA
-
Ventripoint Single Ventricle Study
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI