5 completed, 5 terminated, 2 active not recruiting, 2 recruiting. 18 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 18 | Completed 5, Terminated 5, Active not recruiting 2, Recruiting 2, Unknown 2, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 2 | Unknown 2 |
Follow Heart Septal Defects: new trials by email Literature Review of Heart Septal Defects trials Research Report on Heart Septal Defects
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 |
|---|---|---|---|---|---|---|
| Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy Prasugrel 5mg, Transcatheter Closure of Patent Foramen Ovale - Migraine Disease, Patent Foramen Ovale | Phase 3 | Recruiting | Columbia University | 32 | 2026-10-15 | 2026-10-08 |
| Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy Deep Parasternal intercostal plane block, Erector Spinae Plane Block, conventional analgesic regimen - Septal Defect | Phase 3 | Not yet recruiting | Ain Shams University | 45 | 2025-03-20 | 2025-03-13 |
| PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting, Antiplatelet therapy - Cryptogenic Ischemic Stroke, Patent Foramen Ovale | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 792 | 2023-07-07 | 2026-03-24 |
| A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects L-citrulline, Plasmalyte A - Ventricular Septal Defect, Atrioventricular Septal Defect | Phase 3 | Terminated | Asklepion Pharmaceuticals, LLC | 64 | 2022-06-29 | 2024-09-19 |
| Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia Flecainide - Patent Foramen Ovale, Atrial Arrhythmia | Phase 3 | Active not recruiting | Assistance Publique - Hôpitaux de Paris | 186 | 2022-03-23 | 2026-09-09 |
| Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine PFO closure device, Aspirin and clopidogrel, Triptans - PFO - Patent Foramen Ovale, Migraine | Phase 3 | Active not recruiting | Guangdong Provincial People's Hospital | 440 | 2021-08-12 | 2025-03-12 |
| Iatrogenic Atrial Septal Defect Study (iASD) atrial septal defect closure - Septal Defect, Atrial | Phase 3 | Withdrawn | Henry Ford Health System | 2020-05-06 | 2022-12-08 | |
| Right to Left Cardiac Shunt Detection Flow Detection System - Right to Left Shunt, Patent Foramen Ovale | Phase 3 | Terminated | Cardiox Corporation | 141 | 2012-11-01 | 2015-11-13 |
| Cardiox Shunt Detection Technology Study Cardiox FDS - Patent Foramen Ovale | Phase 3 | Terminated | Cardiox Corporation | 71 | 2011-04-01 | 2013-01-09 |
| Bosentan for Mild Pulmonary Vascular Disease in Asd Patients. Bosentan, Placebo - Heart Septal Defects, Atrial | Phase 3 | Completed | Universitaire Ziekenhuizen KU Leuven | 10 | 2010-10-01 | 2014-03-05 |
| Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence aspirin, Antivitamins K or rivaroxaban or dabigatran or apixaban, Devices for PFO closure - Ischemic Stroke, Patent Foramen Ovale | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 664 | 2007-12-01 | 2017-10-19 |
| The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease Dexmedetomidine - Cardiac Transplant, Patent Ductus Arterious | Phase 3 | Completed | Children's National Research Institute | 41 | 2006-12-01 | 2015-06-26 |
| MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant BioSTAR Septal Repair Implant System, Sham Procedure - Migraine, Aura | Phase 2 / Phase 3 | Unknown | NMT Medical | 610 | 2006-02-01 | 2008-01-25 |
| ESCAPE Migraine Trial PFO Closure with Premere investigational device., Medical management/current medications per standard of care by personal physician. - Migraine Disorders, Heart Septal Defects, Atrial | Phase 3 | Terminated | Abbott Medical Devices | 168 | 2005-11-01 | 2019-02-04 |
| Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation Enalapril, Placebo - Heart Defects, Congenital, Heart Septal Defects, Ventricular | Phase 3 | Terminated | University of Utah | 5 | 2004-12-01 | 2014-03-13 |
| Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) STARFlex septal closure system, Best medical therapy - Patent Foramen Ovale, Stroke | Phase 2 / Phase 3 | Unknown | NMT Medical | 900 | 2003-06-01 | 2008-12-30 |
| Study of Triostat in Infants During Heart Surgery Liothyronine sodium/triiodothyronine, Cardiopulmonary bypass and cardiac surgery - Heart Defects, Congenital | Phase 3 | Completed | Michael Portman | 195 | 2001-04-01 | 2013-08-05 |
| Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest cardiac surgical procedures, cardiopulmonary bypass - Cardiovascular Diseases, Cerebral Anoxia | Phase 3 | Completed | Boston Children's Hospital | 171 | 1988-12-01 | 2016-07-29 |
Foramen Ovale, Patent (10) · Heart Septal Defects, Atrial (7) · Migraine Disorders (6) · Heart Defects, Congenital (4) · Heart Septal Defects, Ventricular (3) · Ischemic Stroke (3) · Stroke (3) · Epilepsy (2) · Atrial Fibrillation (1) · Atrioventricular Septal Defect (1) · Cardiovascular Diseases (1) · Cerebrovascular Disorders (1) · Endocardial Cushion Defects (1) · Headache (1) · Heart Diseases (1)
Cardiovascular Abnormalities (18) · Congenital Abnormalities (18) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (18) · Cardiovascular Diseases (17) · Heart Diseases (17) · Heart Defects, Congenital (14) · Brain Diseases (10) · Central Nervous System Diseases (10) · Nervous System Diseases (10) · Headache Disorders (6) · Headache Disorders, Primary (6) · Heart Septal Defects, Atrial (6) · Vascular Diseases (6) · Cerebrovascular Disorders (5)
Aspirin (2) · Cardiac Surgical Procedures (2) · Cardiopulmonary Bypass (2) · Clopidogrel (2) · Aspirin, Dipyridamole Drug Combination (1) · Bosentan (1) · Citrulline (1) · Dabigatran (1) · Dexmedetomidine (1) · Enalapril (1) · Equipment and Supplies (1) · Factor Xa Inhibitors (1) · Flecainide (1) · Plasmalyte A (1) · Prasugrel Hydrochloride (1)
Assistance Publique - Hôpitaux de Paris (3) · Cardiox Corporation (2) · NMT Medical (2) · Abbott Medical Devices (1) · Ain Shams University (1) · Asklepion Pharmaceuticals, LLC (1) · Boston Children's Hospital (1) · Children's National Research Institute (1) · Columbia University (1) · Guangdong Provincial People's Hospital (1) · Henry Ford Health System (1) · Michael Portman (1) · Universitaire Ziekenhuizen KU Leuven (1) · University of Utah (1)
United States (11) · France (3) · Belgium (1) · Canada (1) · China (1) · Egypt (1)
Mark Reisman, MD (2) · Anthony Furlan, MD (1) · Christopher Mastropietro, MD, FCCM (1) · David Dodick, MD (1) · Gilles Chatellier, MD (1) · Gurdyal Kalsi, MD, MFPM (1) · Jane Newburger (1) · Jean-Louis Mas, MD (1) · Jessica Ailani, MD (1) · Julia C Finkel, MD (1) · LuAnn Minich, MD (1) · Marvin Eng, MD (1) · Michael Portman, MD (1)
PMID 20837917, PMID 21051670, PMID 21163497, PMID 21315203, PMID 21875911, PMID 22417252, PMID 25147037, PMID 25313847, PMID 27056964, PMID 28902593, PMID 29910193, PMID 32381162, PMID 38216511, PMID 38580946, PMID 39222035
R01HL041786 (1), U01HL068269 (1), U01HL068270 (1), U01HL068279 (1), U01HL068281 (1), U01HL068285 (1), U01HL068288 (1), U01HL068290 (1), U01HL068292 (1)