Clinical trials: Heart Septal Defects
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
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
Early Warning of Structural Complications in Perimembranous VSD
The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD.
- Trial name
- NCT07662343
- Where
- China
- Volunteers
- 11,683 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ischemia, Peripheral Arterial Disease (PTA
The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study
ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee
- Conditions
- Ischemia, Peripheral Arterial Disease (PTA, Arterial Occlusive Diseases
- Trial name
- NCT02793349
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- 4 sites in Australia, Netherlands and 1 more
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- The University of New South Wales
Atrial Septal Defect
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
The objective of this post-market study is to: collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder identify previously unknown side-effects
- Trial name
- NCT06849635
- Where
- 6 sites in Poland
- Volunteers
- 139 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
Ventricular Septal Defect
Longterm Outcome After Ventricular Septal Defect Closure
Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy…
- Trial name
- NCT02138435
- Testing
- MRI exercise test, Gas-exchange exercise test
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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.
Patent Foramen Ovale
Russian Registry of Endovascular Closure of PFO
The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided…
- Trial name
- ENDOVAL (NCT06156670)
- Testing
- PFO closure
- Where
- Russia
- Volunteers
- 700 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Stroke, Foramen Ovale, Patent
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism.
- Trial name
- PFO-HUG (NCT01149447)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- University Hospital, Geneva
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
Stroke
Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial…
- Trial name
- NCT06670781
- Testing
- Experimental: Intervention arm: Goal-Directed Valsalva maneuver, Control - standard of care: Self-Directed Valsalva maneuver
- Where
- 2 sites in Canada
- Volunteers
- 488 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Ventricular Septal Defect
Lifetech KONAR MFO Post-Market Clinical Follow-Up Study
The purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).
- Trial name
- NCT04417712
- Testing
- KONAR-MF™ VSD Occluder
- Where
- 4 sites in Germany, Italy
- Volunteers
- 40 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Ventricular Septal Defect
Cera™ VSD Occluder Post Market Clinical Follow-up
The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
- Trial name
- NCT05939713
- Testing
- Cera™ VSD occluder implantation
- Where
- 8 sites in Taiwan
- Volunteers
- 152 people
- Sponsor
- Cardiac Children's Foundation Taiwan
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
Iatrogenic ASD, Mitral Regurgitation
Iatrogenic Atrial Septal Defect Gradient for Intraprocedural Success After M-teer
Transcatheter mitral edge-to-edge repair (M-TEER) has become an established minimally invasive therapy for patients with severe mitral regurgitation (MR) who are at high or prohibitive surgical risk.
- Trial name
- IASIS (NCT07798037)
- Testing
- M-TEER
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Hippocration General Hospital
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
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates
Heart Disease Congenital, Ventricular Septal Defect
Improving Care for Children With Congenital Heart Disease.
Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for…
- Conditions
- Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT04667455
- Testing
- Biomarker analysis at enrolment, Biomarker analyses throughout the study
- Where
- Sweden
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Lund University Hospital