Clinical trials: Atrial Septal Defect (ASD)
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
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
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.
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
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
Congenital Heart Disease, Thiamine Deficiency
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of…
- Conditions
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect
- Trial name
- NCT06298344
- Testing
- Thiamine
- Where
- Indonesia
- Volunteers
- 86 people
- Sponsor
- Universitas Sumatera Utara
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, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
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
Thrombosis
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and…
- Trial name
- NCT01086046
- Testing
- Low molecular weight heparin
- Where
- China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Third Military Medical University
General Anesthesia, Dexmedetomidine
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous…
- Conditions
- General Anesthesia, Dexmedetomidine, Ketamine, Local Infiltration
- Trial name
- NCT06431178
- Testing
- General Anesthesia, Local anesthesia
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
Heart Defects,Congenital, Heart Septal Defects, Atrial
Fluid Balance During Closure of Atrial Septal Defect
This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and…
- Trial name
- NCT01757743
- Where
- Norway
- Volunteers
- 41 people
- Sponsor
- Oslo University Hospital
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
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
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices