Clinical trials: Foramen Ovale, Patent
Hip Fractures
Hip Fracture and Patent Foramen Ovale
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.
- Trial name
- COL-FOP (NCT02564133)
- Testing
- Transthoracic echocardiography
- Where
- 2 sites in France
- Volunteers
- 41 people
- Sponsor
- Hopital Foch
Ischemic Stroke, Patent Foramen Ovale
Patent Foramen Ovale in Cryptogenic Stroke Study
The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.
- Trial name
- PICSS (NCT00697151)
- Testing
- Warfarin, Aspirin
- Where
- United States
- Volunteers
- 630 people
- Sponsor
- Columbia University
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
Obstructive Sleep Apnea, Patent Foramen Ovale
Close Obstructive Sleep Apnea (OSA) Trial
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
- Trial name
- NCT06113562
- Testing
- PFO closure
- Sponsor
- University of Miami
Atrial Septal Defect Secundum
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
- Trial name
- ASO 522 (NCT02353351)
- Testing
- atrial septal occluder
- Where
- 65 sites in United States
- Volunteers
- 602 people
- Sponsor
- Abbott Medical Devices
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
Pulmonary Embolism (PE), Right-to-Left Shunt
Pulmonary Embolism and Right-to-Left Shunts
Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people.
- Conditions
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke, Atrial Septal Defects
- Trial name
- PEaRLS (NCT07519876)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Tufts Medical Center
Stroke, Patent Foramen Ovale
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO…
- Conditions
- Stroke, Patent Foramen Ovale, PFO
- Trial name
- OCCLUFLEX (NCT05069558)
- Testing
- Investigational PFO Closure Device, Standard of Care PFO Closure Device
- Where
- 48 sites in United States, Canada and 6 more
- Volunteers
- 450 people
- Sponsor
- Occlutech International AB
Patent Foramen Ovale, Embolism
Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism
The aim of the project is to identify new risk indicators of PFO. The evaluation of the R-L shunt is based on the newly developed precise measurement technique.
- Trial name
- NCT04610463
- Testing
- Cardiac flow measurement
- Where
- 6 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- University Hospital Hradec Kralove
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Patent Foramen Ovale, Migraine
Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO).
- Trial name
- COMPETE (NCT05546320)
- Testing
- Aspirin 300mg, Metoprolol 25mg, Clopidogrel 75mg
- Where
- 39 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Migraine Headache, PFO - Patent Foramen Ovale
Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)
This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms from patients with…
- Trial name
- MANET (NCT06046508)
- Testing
- blood samples collection
- Where
- 3 sites in Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centro Cardiologico Monzino
Embolic Stroke of Undetermined Source, Ischemic Stroke
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
A stroke is the second cause of deaths after heart attack, one of the most important causes of malfunction as far as adults are concerned and the second as for the frequency cause of dementia.
- Conditions
- Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter, Myocardial Infarction
- Trial name
- NCT03377465
- Testing
- ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medical University of Lodz
Patent Foramen Ovale
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
- Trial name
- NCT05360771
- Testing
- SnowyTM PFO closure system, Cardi-o-fix PFO occluder
- Where
- China
- Volunteers
- 242 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Stroke, PFO - Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a…
- Trial name
- REDUCE PAS (NCT03821129)
- Testing
- PFO closure with GORE® CARDIOFORM Septal Occluder
- Where
- 45 sites in United States
- Volunteers
- 636 people
- Sponsor
- W.L.Gore & Associates
Patent Foramen Ovale
Internal Microstructure of Patent Foramen Ovale Related to Stroke
This study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these…
- Trial name
- IMPORT (NCT04686253)
- Testing
- not appliable
- Where
- 2 sites in China
- Volunteers
- 1,200 people
- Sponsor
- China National Center for Cardiovascular Diseases
Migraine, Migraine With Aura
PRIMA PFO Migraine Trial
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart…
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Trial name
- PRIMA (NCT00505570)
- Testing
- AMPLATZER® PFO Occluder Device
- Where
- 17 sites in Canada, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Migraine Headaches, Patent Foramen Ovale
PREMIUM Migraine Trial
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
- Trial name
- NCT00355056
- Testing
- AMPLATZER PFO Occluder
- Where
- 30 sites in United States
- Volunteers
- 230 people
- Sponsor
- Abbott Medical Devices