Clinical trials: PFO
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
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.
Patent Foramen Ovale
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.
- Trial name
- PFO (NCT02882815)
- Testing
- IrisFIT PFO Occluder
- Where
- 3 sites in Germany, Ireland
- Volunteers
- 85 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Foramen Ovale, Patent
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable…
- Trial name
- PFOCUS (NCT03232450)
- Testing
- Aspirin, Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder
- Where
- United States
- Sponsor
- Mayo Clinic
Silent Stroke, Pulmonary Embolism
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)
Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO).
- Conditions
- Silent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- Trial name
- ICEP (NCT00831259)
- Where
- France
- Volunteers
- 70 people
- Sponsor
- University Hospital, Caen
Varicose Veins
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
- Trial name
- MRI (NCT00442364)
- Testing
- Polidocanol (1%) Microfoam (Varisolve), Endovenous Microfoam Occlusion
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or…
- Trial name
- NCT00335296
- Testing
- PFx catheter
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 100 people
- Sponsor
- Cierra
Foramen Ovale, Patent, Echocardiography
Long-term Outcomes After Percutaneous Closure of PFO
International medical centre Medicor from Slovenia has reported 306 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till June 2022.
- Conditions
- Foramen Ovale, Patent, Echocardiography, Embolic Stroke, Atrial Fibrillation
- Trial name
- NCT05558774
- Where
- Slovenia
- Volunteers
- 300 people
- Sponsor
- MC Medicor
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
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
Patent Foramen Ovale, Stroke
PFO ACCESS Registry
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.
- Trial name
- NCT00583401
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
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
Ischemic Brain Injury, Stroke
Clinical Proteomic Research for the Brain
The study of plasma and urine proteomic profiles in patients with ischemic brain injury is important to better understanding of the mechanisms by which thrombolytic agents or other therapy affects clinical outcomes.
- Conditions
- Ischemic Brain Injury, Stroke, Healthy Individual, Patent Foramen Ovale (PFO)
- Trial name
- "CPR Brain" (NCT00983723)
- Where
- United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Closure of the Foramen Ovale and Ductus Arteriosus
Timing of Closure of Patent Foramen Ovale Following Birth
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent…
- Trial name
- NCT01032785
- Testing
- no interventions
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
Foramen Ovale, Patent, Heart Catheterization
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding…
- Conditions
- Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
- Trial name
- 09k003 (NCT00968032)
- Testing
- Nit-Occlud® PFO
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- pfm medical gmbh
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.
Patent Foramen Ovale, Ischemic Stroke
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- Trial name
- HALTI (NCT04475510)
- Testing
- Antiplatelet treatment discontinuation
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Josep Rodes-Cabau
Foramen Ovale, Patent, Nickel Sensitivity
Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most…
- Conditions
- Foramen Ovale, Patent, Nickel Sensitivity, Dermatitis Contact Irritant, Metal Allergy
- Trial name
- INSPIRE (NCT04713683)
- Testing
- Percutaneous Patent Foramen Ovale Closure
- Where
- Greece
- Volunteers
- 96 people
- Sponsor
- National and Kapodistrian University of Athens