Clinical trials: Heart Septal Defects, Atrial
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
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
Cardiovascular Diseases, Heart Diseases
Reproduction and Survival After Cardiac Defect Repair
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Aortic Valve Stenosis
- Trial name
- NCT00005190
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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 Defects
Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.
The interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with stochastic side effects worrying at the child's.
- Trial name
- CIA3DNAVIGATOR (NCT02529111)
- Testing
- "Echonavigator" software
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Toulouse
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
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.
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
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
Patent Foramen Ovale
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.
- Trial name
- PFO (NCT02882815)
- Testing
- IrisFIT PFO Occluder
- Where
- 3 sites in Germany, Ireland
- Volunteers
- 85 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Heart Septal Defect, Heart Septal Defects, Atrial
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
- Conditions
- Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities
- Trial name
- ASCENT ASD (NCT04591392)
- Testing
- reSept ASD Occluder
- Where
- 32 sites in United States, Canada and 2 more
- Volunteers
- 250 people
- Sponsor
- atHeart Medical
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
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
Patent Foramen Ovale
Long-term Procedural and Device Related Complications of PFO Closure
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
- Trial name
- NCT06413147
- Testing
- PFO closure
- Volunteers
- 100 people
- Sponsor
- Xuanwu Hospital, Beijing
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
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
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
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
Foramen Ovale, Patent, Nickel Sensitivity
Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most…
- Conditions
- Foramen Ovale, Patent, Nickel Sensitivity, Dermatitis Contact Irritant, Metal Allergy
- Trial name
- INSPIRE (NCT04713683)
- Testing
- Percutaneous Patent Foramen Ovale Closure
- Where
- Greece
- Volunteers
- 96 people
- Sponsor
- National and Kapodistrian University of Athens
Migraine, Patent Foramen Ovale
Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing…
- Trial name
- NCT06953622
- Testing
- Conservative treatment, Antipaletet drug, Patent Foramen Ovale Closure
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Peking University Third Hospital