Clinical trials: Patent Foramen Ovale
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
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
Brain Infarction, Ischemic Stroke
Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and…
- Conditions
- Brain Infarction, Ischemic Stroke, Thrombosis, Foramen Ovale, Patent
- Trial name
- SECRETO (NCT01934725)
- Where
- 19 sites in Estonia, Finland and 11 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- SECRETO Study Consortium
Patent Foramen Ovale, Ischemic Stroke
Patent Foramen Ovale Closure in Older Patients
Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism. Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major…
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Older People
- Trial name
- PFO-Elderly (NCT04780022)
- Testing
- Clinical events at last follow-up
- Where
- Canada
- Volunteers
- 350 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Migraine Disorders, Heart Septal Defects, Atrial
ESCAPE Migraine Trial
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who…
- Trial name
- NCT00267371
- Testing
- PFO Closure with Premere investigational device., Medical management/current medications per standard of care by personal physician.
- Where
- 37 sites in United States
- Volunteers
- 168 people
- Sponsor
- Abbott Medical Devices
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; Foramen Ovale
GORE® Septal Occluder European Union Clinical Evaluation
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).
- Trial name
- NCT01605851
- Testing
- Closure, Foramen Ovale
- Where
- 9 sites in Denmark, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
PFO - Patent Foramen Ovale
Amplatzer PFO Occluder Post-marketing Surveillance Study
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical…
- Trial name
- PFO PMS Jpn (NCT04349995)
- Testing
- Amplatzer PFO Occluder
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
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
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
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
Migraine With Aura, Patent Foramen Ovale
Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)
The purpose of the study is to compare the rate of comorbidities associated with migraine aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those who do not have RLS.
- Trial name
- CAMP (NCT01257880)
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Swedish Medical Center
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
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
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
Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source
PFO Occlusion and Atrial Fibrillation
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials.
- Conditions
- Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source, Patent Foramen Ovale
- Trial name
- NCT04898361
- Testing
- PFO closure
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- University Hospital, Saarland
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
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
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.
Patent Foramen Ovale, Intrapulmonary Arteriovenous Anastamosis
Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to…
- Trial name
- NCT03945643
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Oregon