Clinical trials: PFO, active
Epilepsy (treatment Refractory)
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population.
- Trial name
- PREDICT-PFO (NCT06863350)
- Testing
- patent foramen ovale closure
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sichuan University
Stroke, PFO - Patent Foramen Ovale
WSO BEAT STROKE Initiative
The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice…
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Atrial Fibrillation (AF)
- Trial name
- BEAT STROKE (NCT06606054)
- Testing
- Educational and implementation Neurocardiology tool, No educational or implementation tool will be provided
- Where
- Canada
- Volunteers
- 2,400 people
- Sponsor
- Luciano A. Sposato
Stroke, Patent Foramen Ovale
AMPLATZER PFO Occluder Post Approval Study
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
- Trial name
- PFO PAS (NCT03309332)
- Testing
- AMPLATZER™ PFO Occluder
- Where
- 88 sites in United States, Canada and 5 more
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale, Cryptogenic Stroke
Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Transient Ischemic Attack Due to Embolism, Atrial Fibrillation
- Trial name
- NCT07724171
- Where
- South Korea
- Volunteers
- 400 people
- Sponsor
- Yonsei University
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Foramen Ovale, Patent, Stroke, Ischemic
NobleStitch EL STITCH Trial is a PFO Comparative Trial
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
- Trial name
- STITCH (NCT04339699)
- Testing
- NobleStitch™EL Suture Mediated Closure System, Amplatzer PFO Occluder
- Where
- 2 sites in United States, Italy
- Volunteers
- 640 people
- Sponsor
- Nobles Medical Technologies II Inc
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.
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
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
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
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
Migraine With Aura
Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
The PFOCUS Study aims to clarify the relationship between patent foramen ovale (PFO) and migraine with aura (MA). Patients diagnosed with MA according to ICHD-3 criteria will be classified as cases (PFO+) or controls (PFO-) based…
- Trial name
- PFOCUS (NCT07349004)
- Testing
- Intervention
- Where
- Italy
- Volunteers
- 240 people
- Sponsor
- Azienda Usl di Bologna
PFO, PFO - Patent Foramen Ovale
Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS 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 OUS (NCT07698951)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- Serbia
- Volunteers
- 15 people
- Sponsor
- Recross Cardio, Inc.
Patent Foramen Ovale (PFO), High Altitude Pulmonary Edema
The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia
Before birth, the foramen ovale is a normal opening in the heart that allows blood to flow from the mother to the baby. After birth, this opening usually closes.
- Trial name
- NCT07742540
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Stroke, PFO - Patent Foramen Ovale
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Trial name
- GSO-PFO PMS (NCT05529901)
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- W.L.Gore & Associates
PFO, Cognitive
Multimodal Brain Function in Migraine Patients With Patent Foramen Ovale
This investigator-initiated, single-center prospective study is designed to clarify how patent foramen ovale (PFO) relates to brain function abnormalities in patients with drug-refractory migraine with aura (MA), and whether…
- Conditions
- PFO, Cognitive, Cognitive Functions, Migraine
- Trial name
- NEURO-PFO (NCT07343154)
- Volunteers
- 45 people
- Sponsor
- Second Xiangya Hospital of Central South University
Cryptogenic Ischemic Stroke, Patent Foramen Ovale
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80…
- Trial name
- CLOSE-2 (NCT05387954)
- Testing
- Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting, Antiplatelet therapy
- Where
- 42 sites in France
- Volunteers
- 792 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cardiovascular Diseases, Cardiovascular Abnormality
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormality, Heart Defects, Congenital, Heart Septal Defects
- Trial name
- BIOCLOSE-PFO (NCT07300358)
- Testing
- Active Comparator, Experimental
- Volunteers
- 258 people
- Sponsor
- Shanghai Lingsi Medical Technology Co., Ltd.