3 completed, 3 terminated, 2 active not recruiting, 2 recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 3, Terminated 3, Active not recruiting 2, Recruiting 2, Unknown 2, Withdrawn 1 |
| Phase 2 | 2 | Unknown 2 |
Follow Heart Septal Defects, Atrial: new trials by email Literature Review of Heart Septal Defects, Atrial trials Research Report on Heart Septal Defects, Atrial
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 |
| 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 |
| 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| Iatrogenic Atrial Septal Defect Study (iASD) atrial septal defect closure - Septal Defect, Atrial | Phase 3 | Withdrawn | Henry Ford Health System | 2020-05-06 | 2022-12-08 | |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 |
| 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 |
Foramen Ovale, Patent (10) · Migraine Disorders (6) · Ischemic Stroke (3) · Stroke (3) · Epilepsy (2) · Atrial Fibrillation (1) · Headache (1) · Heart Defects, Congenital (1) · Ischemic Attack, Transient (1) · Sleep Apnea, Obstructive (1)
Cardiovascular Abnormalities (13) · Cardiovascular Diseases (13) · Congenital Abnormalities (13) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Heart Diseases (13) · Heart Septal Defects (13) · Heart Defects, Congenital (12) · Brain Diseases (9) · Central Nervous System Diseases (9) · Nervous System Diseases (9) · Headache Disorders (6) · Headache Disorders, Primary (6) · Cerebrovascular Disorders (5) · Vascular Diseases (5)
Aspirin (2) · Clopidogrel (2) · Aspirin, Dipyridamole Drug Combination (1) · Bosentan (1) · Dabigatran (1) · Dexmedetomidine (1) · Equipment and Supplies (1) · Factor Xa Inhibitors (1) · Flecainide (1) · Prasugrel Hydrochloride (1) · Rivaroxaban (1) · Tryptamines (1) · antivitamins K (1) · apixaban (1)
Assistance Publique - Hôpitaux de Paris (3) · Cardiox Corporation (2) · NMT Medical (2) · Abbott Medical Devices (1) · Children's National Research Institute (1) · Columbia University (1) · Guangdong Provincial People's Hospital (1) · Henry Ford Health System (1) · Universitaire Ziekenhuizen KU Leuven (1)
United States (8) · France (3) · Belgium (1) · China (1)
Mark Reisman, MD (2) · Anthony Furlan, MD (1) · David Dodick, MD (1) · Gilles Chatellier, MD (1) · Jean-Louis Mas, MD (1) · Jessica Ailani, MD (1) · Julia C Finkel, MD (1) · Marvin Eng, MD (1) · Michael W Jopling, MD (1) · Robert J Sommer, MD (1) · Robert Sommer, MD (1) · Stewart J. Tepper, MD (1) · Werner Budts, MD, PhD (1)
PMID 21051670, PMID 22417252, PMID 25147037, PMID 25313847, PMID 27056964, PMID 28902593, PMID 29910193, PMID 32381162, PMID 38216511, PMID 38580946, PMID 39222035