Clinical trials: PFO - Patent Foramen Ovale
Migraine, Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
- Conditions
- Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
- Trial name
- RELIEF (NCT04100135)
- Testing
- Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel)
- Where
- 15 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
PFO, PFO - Patent Foramen Ovale
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a…
- Conditions
- PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale
- Trial name
- PROTEA-PFO (NCT07172464)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Recross Cardio, Inc.
Embolic Stroke of Undetermined Source, Transient Ischemic Attack
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD…
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Trial name
- BUBL (NCT04604015)
- Testing
- NeuralBot Investigational System, Transthoracic Echocardiography (TTE)
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Patent Foramen Ovale, Cryptogenic Stroke
Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Embolic Infarction
- Trial name
- LOCATE (NCT07009678)
- Testing
- intravenous access in greater saphenous vein compared to upper extremity site.
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- St. John's Hospital
Thrombosis Cardiac, Atrial Septal Defect
Cerebral Microembolization Associated With PFO Closure
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ…
- Conditions
- Thrombosis Cardiac, Atrial Septal Defect, Patent Foramen Ovale (PFO)
- Trial name
- NCT06347276
- Testing
- PFO occluder; ASD occluder
- Where
- China
- Volunteers
- 800 people
- Sponsor
- China National Center for Cardiovascular Diseases
Atrial Septal Defect, Patent Foramen Ovale
AWARE Registry: Wearable ECG in Structural Heart Interventions
This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type…
- Trial name
- NCT06236776
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Yonsei University
Patent Foramen Ovale, Intrapulmonary Arteriovenous Anastamosis
Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to…
- Trial name
- NCT03945643
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Oregon
Patent Foramen Ovale, Ischemic Stroke
Patent Foramen Ovale Closure in Older Patients
Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism. Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major…
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Older People
- Trial name
- PFO-Elderly (NCT04780022)
- Testing
- Clinical events at last follow-up
- Where
- Canada
- Volunteers
- 350 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Patent Foramen Ovale
Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical…
- Trial name
- NCT00196027
- Testing
- PFX Closure System
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cierra
Embolic Stroke of Undetermined Source
Prospective Registry of Elderly ESUS With PFO
Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS).
- Trial name
- COACH_ESUS (NCT05238610)
- Testing
- PFO closure
- Where
- South Korea
- Volunteers
- 1,200 people
- Sponsor
- Asan Medical Center
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- 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
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale
Anticoagulants for PFO Patients
Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August…
- Trial name
- NCT06375070
- Testing
- PFO closure, anticoagulant
- Volunteers
- 277 people
- Sponsor
- Xuanwu Hospital, Beijing
Brain Infarction, Ischemic Stroke
Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and…
- Conditions
- Brain Infarction, Ischemic Stroke, Thrombosis, Foramen Ovale, Patent
- Trial name
- SECRETO (NCT01934725)
- Where
- 19 sites in Estonia, Finland and 11 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- SECRETO Study Consortium
Foramen Ovale, Patent
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?
- Trial name
- EPIC-FOPCohort (NCT04987008)
- Where
- 3 sites in France
- Volunteers
- 53 people
- Sponsor
- University Hospital, Brest
Migraine Disease, Patent Foramen Ovale
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO).
- Trial name
- COMFORT-PFO (NCT07629635)
- Testing
- Prasugrel 5mg, Transcatheter Closure of Patent Foramen Ovale
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Migraine Disorders, Patent Foramen Ovale
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura.
- Conditions
- Migraine Disorders, Patent Foramen Ovale, Right-to-Left Shunt, Cardiac
- Trial name
- NCT07170176
- Testing
- Percutaneous Patent Foramen Ovale Closure, No Intervention
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Ischemic Stroke, Patent Foramen Ovale
Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke than in control subjects. Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral anticoagulants, and…
- Conditions
- Ischemic Stroke, Patent Foramen Ovale, Atrial Septal Aneurysm, Migraine
- Trial name
- CLOSE (NCT00562289)
- Testing
- aspirin, Antivitamins K or rivaroxaban or dabigatran or apixaban, Devices for PFO closure
- Where
- France
- Volunteers
- 664 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Patent Foramen Ovale (PFO)
Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale.
- Trial name
- NCT07726927
- Testing
- Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
- Volunteers
- 244 people
- Sponsor
- Shenzhen Bihe Medical Co., Ltd
Patent Foramen Ovale
Long-term Procedural and Device Related Complications of PFO Closure
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
- Trial name
- NCT06413147
- Testing
- PFO closure
- Volunteers
- 100 people
- Sponsor
- Xuanwu Hospital, Beijing