Clinical trials: Atrial Septal Defect
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
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
Congenital Heart Diseases, Hemodynamic
Non-Invasive Shunt Quantification in Interatrial Communication
Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler, with the pulmonary-to-systemic blood flow ratio: Qp/Qs.
- Conditions
- Congenital Heart Diseases, Hemodynamic, Cardiac Output
- Trial name
- NISQIC (NCT03437148)
- Testing
- Innocor®, Physioflow®
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University Hospital, Clermont-Ferrand
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, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
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
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, Secundum Type
Assessment of LV/RV S and SR Before and After Percutaneous Closure of ASDs
The effect of Atrial Septal Defect (ASD) closure by using larger devices on the improvement in biventricular function remains an area of active research.
- Trial name
- NCT04091919
- Testing
- 2D- Transthoracic Echocardiography (TTE)
- Where
- 2 sites in Egypt
- Volunteers
- 50 people
- Sponsor
- Ayman khairy Mohamed
Mitral Valve Insufficiency, Heart Septal Defects, Atrial
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.
- Trial name
- NCT03024268
- Testing
- Figulla Flex Occluder (Occlutech)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Heart Center Leipzig - University Hospital
Atrial Septal Defect, Pulmonary Hypertension
Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension
The purpose of the study is to compare exercise capacity, cardiac contractility, pulmonary vascular pressures and heart rate variability between patients with an atrial septal defect and healthy controls.
- Trial name
- NCT03565471
- Testing
- Echocardiography, Right side catheterization, Exercise test
- Where
- Denmark
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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
Secundum Atrial Septal Defects
Occlutech Septal Occluder (Figulla Flex II) Study
The objectives of the study are: To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects To determine the safety of the…
- Trial name
- NCT04488120
- Testing
- transcatheter closure of secundum atrial septal defects in patients
- Volunteers
- 175 people
- Sponsor
- Occlutech International AB
Atrial Septal Defect
Utilization of Confocal Microscopy During Cardiac Surgery
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery.
- Trial name
- NCT03189134
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aditya Kaza
Patent Foramen Ovale, Atrial Septal Defect
Lifetech CeraFlex™ Post-Market Surveillance Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™…
- Conditions
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT02621528
- Testing
- CeraFlex
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect, Patent Foramen Ovale
Canadian Adult Congenital Heart Disease Intervention Registry
The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of…
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale, Tetralogy of Fallot, Fontan
- Trial name
- C-ACHDiR (NCT04288596)
- Testing
- Participants undergoing ACHD intervention
- Where
- Canada
- Volunteers
- 9,000 people
- Sponsor
- University Health Network, Toronto
Atrial Septal Defect
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each).
- Trial name
- NCT04096924
- Testing
- Guidewire for echo-guided interventions, Cook lunderquist guidewire
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai 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
Diseases of Mitral Valve, Aortic Valve Disorder
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
- Conditions
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
- Trial name
- NCT01536717
- Testing
- Articaine hydrochloride 2% solution, Sodium Chloride
- Where
- 2 sites in Finland
- Volunteers
- 36 people
- Sponsor
- Helsinki University Central Hospital
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