Clinical trials: Heart Septal Defects, Atrial
Stroke, Patent Foramen Ovale
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of…
- Conditions
- Stroke, Patent Foramen Ovale, Atrial Fibrillation, Atrial Flutter
- Trial name
- IMPROVE (NCT04738071)
- Testing
- PFO closure
- Where
- Canada
- Volunteers
- 3,730 people
- Sponsor
- Luciano A. Sposato
Atrial Septal Defect
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
This is a proposal, for the first time in Canada, to examine the comparative effectiveness of three commercially available devices (ASO, FSO, and GAO/GSO) for transcatheter closure of atrial septal defects (ASD) in adults using a…
- Trial name
- Trio-ASD (NCT04291898)
- Testing
- AMPLATZER™ Septal Occluder., Occlutech Figulla Flex II®, GORE® CARDIOFORM ASD Occluder
- Where
- 4 sites in Canada
- Volunteers
- 60 people
- Sponsor
- University Health Network, Toronto
Patent Foramen Ovale, Closure; Foramen Ovale
Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke
Among consecutive 47 cryptogenic stroke patients who underwent PFO closure, a serial follow-up bubble contrast TEE at 3 and 9 months after the index procedure was completed in 38 patients (81%, 46±10 years, 19 men).
- Trial name
- NCT03416426
- Testing
- Amplatzer® PFO occluder or Gore® Septal Occluder
- Where
- South Korea
- Volunteers
- 47 people
- Sponsor
- Gachon University Gil Medical Center
Patent Foramen Ovale, Cardiac Implantable Electronic Device
Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli
Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical…
- Trial name
- PARADOX (NCT02378623)
- Testing
- Apixaban
- Where
- United States
- Sponsor
- Mayo Clinic
Foramen Ovale, Patent, Heart Defects, Congenital
InterSEPT: In-Tunnel SeptRx European PFO Trial
The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of…
- Conditions
- Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects
- Trial name
- InterSEPT (NCT01385670)
- Testing
- Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
- Where
- 2 sites in France, Germany
- Volunteers
- 70 people
- Sponsor
- SeptRx, Inc.
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 Septal Defect (ASD), Dexmedetomidine
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters.
- Conditions
- Atrial Septal Defect (ASD), Dexmedetomidine, Delirium - Postoperative, Stress Response
- Trial name
- NCT06631534
- Testing
- Dexmedetomidine
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Patent Foramen Ovale
Does Patent Foramen Ovale Closure Improve Exercise Capacity & Prevent Blood Flow Through Intrapulmonary Shunt
The overarching goal of this study is to examine cardiopulmonary and respiratory physiology pre and post PFO/ASD closure in patients who are undergoing surgical closure of their PFO/ASD.
- Trial name
- PFO CLOSE (NCT03904290)
- Testing
- PFO Closure
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Oregon
Patent Foramen Ovale
Does Patent Foramen Ovale Size Matter in Men and Women
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial.
- Trial name
- NCT03904277
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Oregon
Cardiovascular Diseases, Heart Diseases
Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease
To identify genes involved in the pathogenesis of congenital heart disease, including atrial septal defects (ASDs), paramembranous ventricular septal defects (VSDs), and atrioventricular canal defects (AVCDs).
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Heart Septal Defects, Atrial
- Trial name
- NCT00005322
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Patent Foramen Ovale, Cryptogenic Stroke
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment
- Trial name
- STOP (NCT05907694)
- Testing
- Transcatheter PFO closure, Optimal medical treatment
- Where
- 2 sites in Canada
- Volunteers
- 714 people
- Sponsor
- Josep Rodes-Cabau
Epilepsy (treatment Refractory)
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population.
- Trial name
- PREDICT-PFO (NCT06863350)
- Testing
- patent foramen ovale closure
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sichuan University
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
Atrial Septal Defect
A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children
This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children.
- Trial name
- NCT02276599
- Testing
- Volume expansion
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Brian Schloss
Atrial Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
ASD II, Percutaneous Closure
Echocardiography-guided Oval-shaped ASD Closure
Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter.
- Conditions
- ASD II, Percutaneous Closure, Zero-fluoroscopy
- Trial name
- NCT06526403
- Testing
- Zero-fluoroscopy ASD closure
- Where
- Indonesia
- Volunteers
- 78 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Dynamic T2 Preparation
Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patients With Shunt or Chronic Obstructive Pulmonary Disease
There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet resonance imaging can differentiate between oxygenated and deoxygenated blood.
- Trial name
- NCT02449083
- Testing
- MRI, coronary angiography
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Heart Septal Defects, Atrial, Atrial Septal Defect
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
- Trial name
- NCT03601039
- Testing
- Absnow Absorbable ASD Closure System
- Where
- 14 sites in China
- Volunteers
- 165 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Stroke, PFO - Patent Foramen Ovale
WSO BEAT STROKE Initiative
The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice…
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Atrial Fibrillation (AF)
- Trial name
- BEAT STROKE (NCT06606054)
- Testing
- Educational and implementation Neurocardiology tool, No educational or implementation tool will be provided
- Where
- Canada
- Volunteers
- 2,400 people
- Sponsor
- Luciano A. Sposato