Clinical trials: ASD - Atrial Septal Defect
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
Cardiac Transplant, Patent Ductus Arterious
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis…
- Conditions
- Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
- Trial name
- NCT00480740
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Children's National Research Institute
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
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
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
Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO)
FIH Study With CBSO
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
- Trial name
- NCT01960491
- Testing
- Device Closure of Atrial Septal Defect
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Carag AG
Aortic Coarctation, Cardiomyopathy
Radiation-Free Heart Catheterization Using MRI
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation.
- Conditions
- Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis
- Trial name
- NCT02739087
- Testing
- MRI guided cardiac catheterization, Magnetic resonance imaging
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Joshua Kanter
Migraine
Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
- Trial name
- CANOA (NCT00799045)
- Testing
- Clopidogrel
- Where
- Canada
- Volunteers
- 220 people
- Sponsor
- Laval University
Atrial Septal Defect
The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics
Patients received a MitraClip procedure because of a leakiness of their mitral valves. During this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness.
- Trial name
- MitraClipASD (NCT02453451)
- Testing
- 2D-/3D-TTE, 3D-TEE, Walking Test
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- RWTH Aachen University
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
Right to Left Shunt, Patent Foramen Ovale
Right to Left Cardiac Shunt Detection
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal…
- Conditions
- Right to Left Shunt, Patent Foramen Ovale, Atrial Septal Defect
- Trial name
- PFO Detection (NCT01773252)
- Testing
- Flow Detection System
- Where
- 8 sites in United States
- Volunteers
- 141 people
- Sponsor
- Cardiox Corporation
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
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
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
- Trial name
- ASSURED (NCT02985684)
- Testing
- GORE® CARDIOFORM ASD Occluder
- Where
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
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.
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 Defects, Patent Ductus Arteriosus
Hyperion™ International Registry Trial
The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
- Trial name
- COM-01 (NCT02220270)
- Testing
- ASD and PDA closure
- Where
- 10 sites in Algeria, China and 2 more
- Volunteers
- 200 people
- Sponsor
- European Cardiovascular Research Center
Atrial Septal Defects
Safety and Effectiveness Study of the Solysafe Septal Occluder
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)
- Trial name
- NCT00353509
- Testing
- Device Closure of a Septal Defect
- Where
- Serbia
- Sponsor
- Carag AG
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
Atrial Septal Defect (ASD)
A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment.
- Trial name
- PANNA-ASD (NCT07054541)
- Testing
- Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention
- Where
- China
- Volunteers
- 666 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital