Clinical trials: PFO
Cardiovascular Diseases
New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure
Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS.
- Trial name
- NCT06983613
- Where
- 2 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- Na Homolce 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.
Stroke, Foramen Ovale, Patent
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism.
- Trial name
- PFO-HUG (NCT01149447)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- University Hospital, Geneva
Migraine
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9…
- Trial name
- NCT00369499
- Testing
- PFO Closure
- Where
- Germany
- Volunteers
- 656 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale
Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
- Trial name
- CAPPRES (NCT05592301)
- Testing
- Diffusion-weighted Magnetic Resonance Imaging (DW-MRI), Transcranial Doppler (TCD), Transthoracic Echocardiogram (TTE)
- Where
- Canada
- Volunteers
- 408 people
- Sponsor
- University Health Network, Toronto
PFO - Patent Foramen Ovale, Migraine
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
- Trial name
- SPRING (NCT04946734)
- Testing
- PFO closure device, Aspirin and clopidogrel, Triptans
- Where
- 21 sites in China
- Volunteers
- 440 people
- Sponsor
- Guangdong Provincial People's Hospital
Stroke
Atrial Fibrillation After PFO Closure
An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies.
- Trial name
- AFEPFO (NCT04290052)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Montpellier
Atrial Septal Defect, Patent Foramen Ovale
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).
- Trial name
- NCT00207376
- Testing
- Solysafe Septal Occluder
- Where
- Germany
- Sponsor
- Carag AG
Embolic Stroke of Undetermined Source
Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke
Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic stroke of undetermined source (ESUS).
- Trial name
- Catch-up-ESUS (NCT03820375)
- Where
- Germany
- Volunteers
- 750 people
- Sponsor
- Ludwig-Maximilians - University of Munich
Patent Foramen Ovale
Russian Registry of Endovascular Closure of PFO
The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided…
- Trial name
- ENDOVAL (NCT06156670)
- Testing
- PFO closure
- Where
- Russia
- Volunteers
- 700 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Patent Foramen Ovale, Stroke
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO…
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Trial name
- NCT00201461
- Testing
- STARFlex septal closure system, Best medical therapy
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- NMT Medical
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
PFO - Patent Foramen Ovale, Migraine
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults.
- Conditions
- PFO - Patent Foramen Ovale, Migraine, Migraine Headache, Migraine Headache, With or Without Aura
- Trial name
- BioMetal (NCT06203873)
- Testing
- Biodegradable occluder, Metal occluder
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
Patent Foramen Ovale (PFO)
Non-Invasive Detection of Right-to-Left Cardiac Shunts
This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt
- Trial name
- HEADBAND (NCT07420400)
- Testing
- Point-of-care ultrasound
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Scripps Health
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
Foramen Ovale, Patent, Septal Defect, Atrial
Stitch Closure of PFO and Septal Repair
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal…
- Conditions
- Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
- Trial name
- STITCH (NCT03373929)
- Testing
- PFO Closure Rate, Published PFO Device Closure
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- HeartStitch.Com
Patent Foramen Ovale, Cryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
- Trial name
- NCT05537753
- Testing
- Encore PFO closure device, FDA-approved PFO closure device
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Encore Medical Inc.
Stroke, Transient Ischemic Attack
International PFO Consortium
The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke).
- Trial name
- NCT00859885
- Testing
- Antithrombotic treatment, percutaneous device closure of PFO
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 1,500 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Ischemic Stroke, Embolic Stroke of Undetermined Source
SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort…
- Conditions
- Ischemic Stroke, Embolic Stroke of Undetermined Source, Patent Foramen Ovale (PFO), Elderly
- Trial name
- SENIOR (NCT07479147)
- Testing
- PFO closure, Medication
- Where
- 3 sites in Taiwan
- Volunteers
- 400 people
- Sponsor
- Taichung Veterans General Hospital