11 completed, 7 active not recruiting, 7 recruiting, 5 unknown. 18 Not applicable, 2 Phase 3, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 18 | Active not recruiting 5, Completed 5, Recruiting 5, Unknown 3 |
| Phase 3 | 2 | Completed 1, Unknown 1 |
| Phase 2 | 1 | Unknown 1 |
| Phase 4 | 1 | Recruiting 1 |
Follow Pulmonary Valve Insufficiency: new trials by email Literature Review of Pulmonary Valve Insufficiency trials Research Report on Pulmonary Valve Insufficiency
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| PULSTA TPV Observational Study Heart Disease | Not yet recruiting | Taewoong Medical Co., Ltd. | 200 | 2026-10-01 | 2026-08-10 | |
| Harmony TPV EMEA PMS Certain imaging assessments can be non-Standard of Care - Severe Pulmonary Valve Regurgitation | Not applicable | Recruiting | Medtronic Cardiovascular | 80 | 2025-07-30 | 2026-07-14 |
| Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial SGLT2 inhibitor (Dapagliflozin 10mg) - Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF) | Phase 4 | Recruiting | The University of Hong Kong | 106 | 2025-05-12 | 2025-05-20 |
| VenusP-Valve Pivotal Study (PROTEUS STUDY) Transcatheter pulmonary valve implantation (TPVI), VenusP-ValveTM System - Pulmonary Regurgitation | Not applicable | Recruiting | Venus MedTech (HangZhou) Inc. | 60 | 2024-06-11 | 2025-02-28 |
| Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve GrOwnValve - novel heart valve replacement approach - Pulmonary Valve Insufficiency | Not applicable | Recruiting | Charite University, Berlin, Germany | 7 | 2023-12-18 | 2025-09-29 |
| Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction Polyurethane expandable valve stent implant - Valvulopathy | Not applicable | Unknown | Dr. Miguel Angel Maluf | 5 | 2022-10-01 | 2022-04-01 |
| ALTERRA Post-Approval Study Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System - Pulmonary Valve Insufficiency, Complex Congenital Heart Defect | Active not recruiting | Edwards Lifesciences | 150 | 2022-05-12 | 2026-10-05 | |
| Harmony TPV Post-Approval Study Harmony TPV System - Congenital Heart Disease, Tetrology of Fallot | Not applicable | Active not recruiting | Medtronic Cardiovascular | 174 | 2021-10-25 | 2026-10-01 |
| COMPASSION S3 Post-Approval Study SAPIEN 3 THV - Complex Congenital Heart Defect, Dysfunctional RVOT Conduit | Active not recruiting | Edwards Lifesciences | 150 | 2021-04-13 | 2026-02-03 | |
| Berlin Registry of Right Heart Interventions Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband) - Tricuspid Regurgitation, Pulmonary Regurgitation | Recruiting | Charite University, Berlin, Germany | 200 | 2020-06-16 | 2026-03-19 | |
| Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot Programmed ventricular stimulation - Congenital Heart Disease, Fallot Tetralogy | Unknown | Paris Cardiovascular Research Center (Inserm U970) | 100 | 2020-01-01 | 2021-03-09 | |
| PULSTA Transcatheter Pulmonary Valve Pre-Approval Study PULSTA TPV System - Heart Diseases, Pulmonary Valve Regurgitation | Not applicable | Active not recruiting | Taewoong Medical Co., Ltd. | 58 | 2019-10-07 | 2026-04-13 |
| Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation Pulmonary valve replacement - Tetralogy of Fallot, Pulmonary Regurgitation | Not applicable | Recruiting | Copenhagen University Hospital, Rigshospitalet | 120 | 2019-04-01 | 2019-09-10 |
| Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction GORE PV1 - Heart Defects, Congenital, Tetralogy of Fallot | Not applicable | Active not recruiting | W.L.Gore & Associates | 15 | 2018-06-07 | 2026-02-05 |
| ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent Edwards Alterra Adaptive Prestent with SAPIEN 3 THV - Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR) | Not applicable | Active not recruiting | Edwards Lifesciences | 86 | 2017-08-22 | 2026-10-20 |
| COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction SAPIEN XT THV - Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis | Completed | Edwards Lifesciences | 57 | 2017-07-17 | 2025-12-15 | |
| The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study Harmony TPV System - Congenital Heart Disease, Tetrology of Fallot | Not applicable | Active not recruiting | Medtronic Heart Valves | 86 | 2017-01-01 | 2025-09-19 |
| Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts trans catheter heart valve replacement - Pulmonary Regurgitation | Not applicable | Unknown | Venus MedTech (HangZhou) Inc. | 84 | 2016-08-17 | 2023-04-21 |
| Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease Acquisition of pressure-volume-loops - Pulmonary Regurgitation, Congenital Heart Disease | Not applicable | Unknown | Heart Center Leipzig - University Hospital | 40 | 2016-07-07 | 2021-05-10 |
| COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV - Complex Congenital Heart Defect, Dysfunctional RVOT Conduit | Not applicable | Recruiting | Edwards Lifesciences | 108 | 2016-07-05 | 2026-07-23 |
Showing 20 of 31. Sign in to see all of them.
Tetralogy of Fallot (16) · Heart Defects, Congenital (11) · Pulmonary Valve Stenosis (11) · Heart Diseases (5) · Aortic Valve Disease (2) · Constriction, Pathologic (2) · Gastroesophageal Reflux (2) · Pulmonary Atresia (2) · Ventricular Dysfunction, Right (2) · Airway Obstruction (1) · Aortic Valve Insufficiency (1) · Aortic Valve Stenosis (1) · Bites and Stings (1) · Cardiovascular Abnormalities (1)
Cardiovascular Diseases (30) · Heart Valve Diseases (30) · Heart Diseases (26) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (21) · Cardiovascular Abnormalities (20) · Congenital Abnormalities (20) · Ventricular Outflow Obstruction (11) · Heart Defects, Congenital (10) · Pathological Conditions, Signs and Symptoms (3) · Respiratory Tract Diseases (3) · Deglutition Disorders (2) · Digestive System Diseases (2) · Esophageal Diseases (2) · Esophageal Motility Disorders (2) · Gastrointestinal Diseases (2)
Sodium-Glucose Transporter 2 Inhibitors (1) · dapagliflozin (1)
Edwards Lifesciences (8) · Charite University, Berlin, Germany (2) · Medtronic Cardiovascular (2) · Taewoong Medical Co., Ltd. (2) · Venus MedTech (HangZhou) Inc. (2) · Assistance Publique - Hôpitaux de Paris (1) · Boston Children's Hospital (1) · Copenhagen University Hospital, Rigshospitalet (1) · CryoLife, Inc. (1) · Dr. Miguel Angel Maluf (1) · Heart Center Leipzig - University Hospital (1) · Johns Hopkins University (1) · Medtronic Heart Valves (1) · Paris Cardiovascular Research Center (Inserm U970) (1) · Seoul National University Hospital (1)
United States (15) · Germany (7) · Italy (4) · France (3) · Israel (3) · South Korea (3) · Spain (3) · Turkey (Türkiye) (3) · Canada (2) · Denmark (2) · Ireland (2) · Netherlands (2) · Poland (2) · Belgium (1) · Brazil (1)
Boris Schmitt, Dr. (1) · Charles B Higgins, MD (1) · Christopher Baird, MD (1) · Chun-Ka Dr Wong, Clinical Assistant Professor (1) · D. Scott Lim, MD (1) · David Balzer, MD (1) · Dorte G Nielsen, MD, PhD (1) · Ender Odemis, PhD. MD. (1) · Evan Zahn, MD, FACC, FSCAI (1) · Federico Gutierrez Larraya, PhD. MD. (1) · Gi Beom Kim, PhD. MD (1) · Gi Beom Kim, PhD. MD. (1) · Gregor Krings, PhD. MD. (1) · Helle Andersen, MD (1)
PMID 17572925, PMID 20837914, PMID 20970202, PMID 24824357, PMID 26114442, PMID 29222139, PMID 29663436, PMID 29871940, PMID 30354627, PMID 31351553, PMID 31535829, PMID 31980166, PMID 33197559, PMID 33826508, PMID 34405863, PMID 34656466, PMID 35487320, PMID 36171554, PMID 36605072, PMID 37170812, PMID 37278682, PMID 37435053, PMID 37615988, PMID 37622666, PMID 38162132, PMID 38430085, PMID 40665900, PMID 41657206, PMID 41884901, PMID 42312408
P50HL074734 (1)