Clinical trials: Atrial Septal Defects, open to volunteers
Atrial Septal Defect, Successful Device Closure
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape.
- Trial name
- ASD (NCT02097758)
- Testing
- Transcatheter device closure
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
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
ASD, Brady Arrythmia
Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
Primary outcomes : Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure Secondary outcomes …
- Trial name
- NCT06761807
- Testing
- Electrophysiology study of heart
- Volunteers
- 65 people
- Sponsor
- Assiut University
Atrial Septal Defect (ASD)
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
The objective of this PMCF study is to: confirm the safety and performance of the AcuMarkTM Sizing Balloon identify previously unknown side-effects monitor the identified side-effects (related to the procedure or to the medical…
- Trial name
- NCT06700174
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
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
ASD2(Secundum Atrial Septal Defect)
Dapagliflozin and Right Heart Recovery After ASD Device Closure
The aim of this study is to evaluate the clinical and echocardiographic influence of dapagliflozin on right ventricular reverse remodeling in adult patients following successful transcatheter Atrial Septal Defect (ASD) device…
- Trial name
- NCT07823972
- Testing
- trans catheter device closure
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Assiut University
Atrial Fibrillation, Atrial Septal Defect
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8…
- Conditions
- Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
- Trial name
- Eight-CLOVER (NCT07827287)
- Testing
- Perclose ProStyle™ Suture-Mediated Closure System, Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Ewha Womans University Mokdong Hospital
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Trial name
- NCT05774288
- Testing
- Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
- Where
- 14 sites in China
- Volunteers
- 244 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular Diseases, Cardiovascular Abnormality
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormality, Heart Defects, Congenital, Heart Septal Defects
- Trial name
- BIOCLOSE-PFO (NCT07300358)
- Testing
- Active Comparator, Experimental
- Volunteers
- 258 people
- Sponsor
- Shanghai Lingsi Medical Technology Co., Ltd.
Thrombosis Cardiac, Atrial Septal Defect
Cerebral Microembolization Associated With PFO Closure
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ…
- Conditions
- Thrombosis Cardiac, Atrial Septal Defect, Patent Foramen Ovale (PFO)
- Trial name
- NCT06347276
- Testing
- PFO occluder; ASD occluder
- Where
- China
- Volunteers
- 800 people
- Sponsor
- China National Center for Cardiovascular Diseases
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
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
Migraine With Aura
Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
The PFOCUS Study aims to clarify the relationship between patent foramen ovale (PFO) and migraine with aura (MA). Patients diagnosed with MA according to ICHD-3 criteria will be classified as cases (PFO+) or controls (PFO-) based…
- Trial name
- PFOCUS (NCT07349004)
- Testing
- Intervention
- Where
- Italy
- Volunteers
- 240 people
- Sponsor
- Azienda Usl di Bologna
ASD - Atrial Septal Defect
A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden.
- Trial name
- NCT07273227
- Testing
- Mobile Surgical Vehicle Echocardiography-guided ASD closure Group, Conventional Operating Room Echocardiography-guided ASD closure Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Cryptogenic Ischemic Stroke, Patent Foramen Ovale
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80…
- Trial name
- CLOSE-2 (NCT05387954)
- Testing
- Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting, Antiplatelet therapy
- Where
- 42 sites in France
- Volunteers
- 792 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Atrial Fibrillation, Atrial Flutter
Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure
"The primary objective of the study is to evaluate whether the incidence of symptomatic or asymptomatic atrial fibrillation, atrial flutter, and atrial tachycardia within 30 days after percutaneous closure of idiopathic patent…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Heart Septal Defects, Atrial
- Trial name
- BRAVE PFO (NCT07123506)
- Testing
- Beta-blocker treatment group, Non-treatment group
- Where
- South Korea
- Volunteers
- 350 people
- Sponsor
- Yonsei University
Sinus Venosus Defect, Congenital Heart Disease
OPTImal Treatment of Sinus VENOSUS Defect
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect.
- Conditions
- Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
- Trial name
- OPTIVENOSUS (NCT05865119)
- Testing
- OPTIMUS covered stent, Surgical correction of a SVD
- Where
- 13 sites in France
- Volunteers
- 60 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
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.