Clinical trials: Atrial Septal Defect
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
Cerebral Infarction
Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS)
We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory.
- Trial name
- ICONS (NCT01429948)
- Where
- South Korea
- Volunteers
- 581 people
- Sponsor
- Samsung Medical Center
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
Cryptogenic Stroke, Foramen Ovale, Patent
Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.
- Conditions
- Cryptogenic Stroke, Foramen Ovale, Patent, Atrial Fibrillation
- Trial name
- ALFA-ROMEO (NCT04881578)
- Testing
- continuous cardiac monitoring before and after transcatheter PFO closure
- Where
- 6 sites in Switzerland
- Volunteers
- 200 people
- Sponsor
- Raban Jeger
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
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
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
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
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
Foramen Ovale, Patent, Migraine
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
- Trial name
- EASTFORM (NCT02127294)
- Testing
- transcatheter patent foreman ovale closure
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Yi Yang
Platelet Aggregation, Spontaneous, Migraine With Aura
pLatelEts And MigRaine iN patEnt foRamen Ovale
Migraine is a common, chronic neurovascular disorder characterized by attacks of severe headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling neurological symptoms.
- Conditions
- Platelet Aggregation, Spontaneous, Migraine With Aura, Patent Foramen Ovale
- Trial name
- LEARNER (NCT03521193)
- Testing
- patent foramen ovale closure
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Centro Cardiologico Monzino
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
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
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
Foramen Ovale Patent
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles)…
- Trial name
- NCT02351076
- Where
- Czechia
- Volunteers
- 44 people
- Sponsor
- University Hospital Ostrava
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
Congenital Disorders
Pulmonary Hypertension in Trisomy 21 Patients
Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect.
- Trial name
- NCT00478296
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Healthcare of Atlanta
Ischemic Stroke, Patent Foramen Ovale
Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke than in control subjects. Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral anticoagulants, and…
- Conditions
- Ischemic Stroke, Patent Foramen Ovale, Atrial Septal Aneurysm, Migraine
- Trial name
- CLOSE (NCT00562289)
- Testing
- aspirin, Antivitamins K or rivaroxaban or dabigatran or apixaban, Devices for PFO closure
- Where
- France
- Volunteers
- 664 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Atrial Septal Defect
Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Atrial septal defects (ASD) account for 10% of all congenital heart defects [1]. Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the…
- Trial name
- NCT05540769
- Testing
- catheter guided ASD closure
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University