6 recruiting, 2 active not recruiting, 2 completed, 2 terminated. 7 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 7 | Recruiting 5, Not yet recruiting 1, Terminated 1 |
| Phase 3 | 1 | Active not recruiting 1 |
Follow PFO - Patent Foramen Ovale: new trials by email Literature Review of PFO - Patent Foramen Ovale trials Research Report on PFO - Patent Foramen Ovale
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 |
|---|---|---|---|---|---|---|
| WSO BEAT STROKE Initiative Educational and implementation Neurocardiology tool, No educational or implementation tool will be provided - Stroke, PFO - Patent Foramen Ovale | Not applicable | Not yet recruiting | Luciano A. Sposato | 2400 | 2027-03-01 | 2026-09-18 |
| Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study Recross P3 Occluder (P3O) System - PFO, PFO - Patent Foramen Ovale | Not applicable | Recruiting | Recross Cardio, Inc. | 15 | 2026-06-17 | 2026-07-13 |
| Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device Transcranial Ultrasound Device - Hereditary Haemorrhagic Telangiectasia, PFO - Patent Foramen Ovale | Not applicable | Recruiting | St. Antonius Hospital | 40 | 2026-01-07 | 2026-02-17 |
| Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study Recross P3 Occluder (P3O) System - PFO, PFO - Patent Foramen Ovale | Not applicable | Recruiting | Recross Cardio, Inc. | 30 | 2025-10-09 | 2026-07-27 |
| Abbott Structural Heart Device Registry Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices - Heart Diseases, ASD - Atrial Septal Defect | Recruiting | Abbott Medical Devices | 2500 | 2024-08-21 | 2026-09-01 | |
| A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine Biodegradable occluder, Metal occluder - PFO - Patent Foramen Ovale, Migraine | Not applicable | Recruiting | Chinese Academy of Medical Sciences, Fuwai Hospital | 400 | 2024-03-01 | 2025-12-04 |
| Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET) blood samples collection - Migraine Headache, PFO - Patent Foramen Ovale | Unknown | Centro Cardiologico Monzino | 120 | 2023-05-18 | 2024-02-08 | |
| Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder GORE® CARDIOFORM Septal Occluder - Stroke, PFO - Patent Foramen Ovale | Active not recruiting | W.L.Gore & Associates | 300 | 2022-10-03 | 2025-11-20 | |
| COMPETE Cohort Study PFO occlusion - PFO - Patent Foramen Ovale, Migraine | Unknown | Chinese Academy of Medical Sciences, Fuwai Hospital | 242 | 2022-01-01 | 2023-09-13 | |
| 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 |
| GORE® CARDIOFORM Septal Occluder Migraine Clinical Study Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel), Sham device PFO closure - Migraine, Patent Foramen Ovale | Not applicable | Terminated | W.L.Gore & Associates | 7 | 2021-02-05 | 2026-06-09 |
| Trevisio Post-Approval Study Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder - PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect | Completed | Abbott Medical Devices | 254 | 2020-09-14 | 2026-03-16 | |
| The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO Occlutech PFO Occluder - Stroke, PFO - Patent Foramen Ovale | Terminated | Occlutech International AB | 582 | 2019-10-03 | 2024-09-19 | |
| Amplatzer PFO Occluder Post-marketing Surveillance Study Amplatzer PFO Occluder - PFO - Patent Foramen Ovale | Completed | Abbott Medical Devices | 500 | 2019-10-01 | 2026-06-01 | |
| GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study PFO closure with GORE® CARDIOFORM Septal Occluder - Stroke, PFO - Patent Foramen Ovale | Not applicable | Recruiting | W.L.Gore & Associates | 636 | 2019-07-25 | 2026-07-30 |
Foramen Ovale, Patent (15) · Migraine Disorders (5) · Ischemic Stroke (4) · Stroke (4) · Heart Septal Defects, Atrial (2) · Atrial Fibrillation (1) · Heart Diseases (1) · Heart Valve Diseases (1) · Migraine with Aura (1) · Pulmonary Arteriovenous Fistulas (1) · Telangiectasia, Hereditary Hemorrhagic (1)
Cardiovascular Abnormalities (15) · Cardiovascular Diseases (15) · Congenital Abnormalities (15) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (15) · Heart Defects, Congenital (15) · Heart Septal Defects (15) · Heart Diseases (14) · Heart Septal Defects, Atrial (13) · Brain Diseases (12) · Central Nervous System Diseases (12) · Nervous System Diseases (12) · Cerebrovascular Disorders (7) · Vascular Diseases (7) · Headache Disorders (5) · Headache Disorders, Primary (5)
Clopidogrel (2) · Drug Delivery Systems (2) · Aspirin (1) · Prasugrel Hydrochloride (1) · Septal Occluder Device (1) · Tryptamines (1) · thienopyridine (1)
Abbott Medical Devices (3) · W.L.Gore & Associates (3) · Chinese Academy of Medical Sciences, Fuwai Hospital (2) · Recross Cardio, Inc. (2) · Centro Cardiologico Monzino (1) · Guangdong Provincial People's Hospital (1) · Luciano A. Sposato (1) · Occlutech International AB (1) · St. Antonius Hospital (1)
Italy (4) · United States (4) · China (3) · France (3) · Germany (3) · Canada (2) · Japan (2) · Netherlands (2) · Poland (2) · Spain (2) · Denmark (1) · Estonia (1) · Ireland (1) · Serbia (1) · Switzerland (1)
Barathi Sethuraman (1) · Daniela Trabattoni, MD (1) · David Dodick, MD (1) · Martijn C. Post, Professor (1) · Mary Seale (1) · Robert Sommer, MD (1)