Clinical trials: Atrial Septal Defect (ASD)
Foramen Ovale, Patent, Heart Septal Defects, Atrial
The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be identified and reviewed in cardiology clinics.
- Conditions
- Foramen Ovale, Patent, Heart Septal Defects, Atrial, Atrial Septal Defect
- Trial name
- EPIC (NCT02957201)
- Testing
- Blood samples
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
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 Septal Defect
International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients
The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal defects (ASD II).
- Trial name
- IRFACODE-II (NCT02766569)
- Testing
- ASD closure with the Occlutech Flex II ASD closure device
- Volunteers
- 2,000 people
- Sponsor
- Ludwig-Maximilians - University of Munich
Atrial Septal Defect
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
- Trial name
- NCT05887700
- Testing
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Where
- 10 sites in Brazil, Greece and 1 more
- Volunteers
- 145 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
ASD2(Secundum Atrial Septal Defect)
Outcomes of Transcatheter ASD Closure Guided by 3D-TEE
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance…
- Trial name
- NCT03867708
- Testing
- ASD device closure
- Sponsor
- Assiut University
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
Atrial Septal Defect (ASD)
Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure.
- Trial name
- NCT06655935
- Testing
- Ordinary Transcatheter ASD closure, modified transcatheter ASD closure
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Egyptian Biomedical Research Network
Atrial Septal Defect, Patent Foramen Ovale
AWARE Registry: Wearable ECG in Structural Heart Interventions
This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type…
- Trial name
- NCT06236776
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Yonsei University
Atrial Septal Defect
Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy.
- Trial name
- NCT07529028
- Testing
- Absnow II Absorbable Atrial Septal Defect Occluder System, Cera Atrial Septal Defect Occluder
- Volunteers
- 236 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Atrial Septal Defects, Ventricular Septal Defects
Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions
Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.
- Trial name
- NCT02552485
- Testing
- No intervention was applied, because it is an observational study
- Where
- Belgium
- Volunteers
- 93 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
Atrial Septal Defect
The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion.
- Trial name
- NCT05371366
- Testing
- ASD closure with the novel occluder (ReAces), ASD closure with normal occluder
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Septal Defect, Atrial
Iatrogenic Atrial Septal Defect Study (iASD)
This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore…
- Trial name
- iASD (NCT04395027)
- Testing
- atrial septal defect closure
- Where
- United States
- Sponsor
- Henry Ford Health System
Atrial Septal Defect
Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect.
- Trial name
- NCT06139679
- Testing
- ASD closure with fenestrated/non-fenestrated patch
- Where
- Indonesia
- Volunteers
- 21 people
- Sponsor
- Dr. Soetomo General Hospital
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
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
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Atrial Septal Defect, Patent Foramen Ovale
Nickel Allergy With Septal Closure Devices
This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO] or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates the top two (2) chambers of the heart.
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale, Allergic Reaction to Nickel
- Trial name
- NASAH (NCT01068366)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Utah