Clinical trials: Foramen Ovale, Patent
Patent Foramen Ovale, Obstructive Sleep Apnea
PFO Closure for Obstructive Sleep Apnoea
Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted breathing during sleep due to repetitive narrowing or collapse of the throat.
- Trial name
- PCOSA-1 (NCT02771561)
- Testing
- Patent Foramen Ovale Closure
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
Patent Foramen Ovale, PFO
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
- Trial name
- NCT05893758
- Testing
- The Cera™ PFO Occluder
- Where
- 5 sites in Poland
- Volunteers
- 94 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Apnea Syndrome, Stroke
Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Victims of Cryptogenic Ischemic Stroke
Obstructive sleep apnea syndrome (OSAS) and patent foramen ovale (FOP) are considered as risk factors for stroke. OSAS generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of…
- Trial name
- NCT04846205
- Testing
- systematic etiological
- Where
- France
- Volunteers
- 159 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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
Patent Foramen Ovale
Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults.
- Trial name
- NCT04549272
- Testing
- No interventions
- Volunteers
- 100 people
- Sponsor
- Neuromed IRCCS
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
Patent Foramen Ovale
CeraFlex PFO Closure System PMCF Study
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
- Trial name
- NCT06120270
- Testing
- CeraFlex PFO Closure System
- Where
- 15 sites in Germany, South Korea
- Volunteers
- 180 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Foramen Ovale, Patent, Heart Septal Defects, Atrial
The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be identified and reviewed in cardiology clinics.
- Conditions
- Foramen Ovale, Patent, Heart Septal Defects, Atrial, Atrial Septal Defect
- Trial name
- EPIC (NCT02957201)
- Testing
- Blood samples
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
Patent Foramen Ovale
Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and septum secondum composing the interatrial septum.
- Trial name
- IDFFOP (NCT03828825)
- Testing
- Patent Foramen Ovale closure
- Where
- 3 sites in France
- Volunteers
- 279 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Patent Foramen Ovale, Atrial Fibrillation
Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen…
- Conditions
- Patent Foramen Ovale, Atrial Fibrillation, Stroke
- Trial name
- PFO-AF (NCT04926142)
- Testing
- Implantation of Holter device, Percutaneous PFO closure
- Where
- 4 sites in France
- Volunteers
- 250 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Migraine, Patent Foramen Ovale
COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO).
- Trial name
- NCT05561660
- Testing
- PFO device closure, Aspirin
- Where
- China
- Volunteers
- 460 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
Stroke, PFO - Patent Foramen Ovale
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
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
- Trial name
- PROOF (NCT04029233)
- Testing
- Occlutech PFO Occluder
- Where
- 17 sites in Canada, France and 2 more
- Volunteers
- 582 people
- Sponsor
- Occlutech International AB
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
Patent Foramen Ovale
Cardiox Shunt Detection Technology Study
The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS).
- Trial name
- NCT01333761
- Testing
- Cardiox FDS
- Where
- 7 sites in United States
- Volunteers
- 71 people
- Sponsor
- Cardiox Corporation
Foramen Ovale, Patent, Decompression Sickness
Decompression Sickness in Divers With or Without Patent Foramen Ovale
The investigators will prospectively estimate incidences of decompression sickness in SCUBA divers with or without patent foramen ovale (PFO).
- Trial name
- DIVER-PFO (NCT02432131)
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sejong General Hospital
Patent Oval Foramen
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter.
- Trial name
- NCT06793969
- Testing
- Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage, Conventional technique to pass the PFO tunnel
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RenJi Hospital
Patent Foramen Ovale, PFO
Emergency/Compassionate Use PFO Occluder
Emergency/compassionate use for the AMPLATZER PFO Occluder
- Trial name
- NCT00584064
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale, Stroke
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder…
- Conditions
- Patent Foramen Ovale, Stroke, Transient Ischemic Attack (TIA)
- Trial name
- SAFE-PFO (NCT07380490)
- Testing
- PFO Closure procedure
- Where
- Germany
- Volunteers
- 1,260 people
- Sponsor
- Giuseppe Tarantini
ASD2(Secundum Atrial Septal Defect)
Outcomes of Transcatheter ASD Closure Guided by 3D-TEE
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance…
- Trial name
- NCT03867708
- Testing
- ASD device closure
- Sponsor
- Assiut University