Clinical trials: Atrial Septal Defect
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.
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
Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
This prospective observational cohort study evaluates a precision neuromuscular management strategy in pediatric patients undergoing minimally invasive cardiac surgery (MICS).
- Conditions
- Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery, Early Extubation Pathway, TOF-Guided Sugammadex Administration
- Trial name
- TOF (NCT07798011)
- Testing
- Sugammadex
- Where
- Vietnam
- Volunteers
- 80 people
- Sponsor
- Dr. Nguyen Thi Thu Hang
Atrial Septal Defect, Ventricular Septal Defects
Comparison of Dynamic Compliance and Airway Resistance in Pressure-Controlled Versus Volume-Controlled Ventilation in Children Undergoing Corrective Heart Surgery
The goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children. The children in this study were born with a hole inside the heart.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defects, Pulmonary Hypertension, Intracardiac and Septal Defects
- Trial name
- NCT07754591
- Testing
- Pressure Controlled Ventilation, Volume Controlled Ventilation
- Where
- India
- Volunteers
- 72 people
- Sponsor
- Nilratan Sircar Medical College
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
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.
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
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 (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
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
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.
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
ASD - Atrial Septal Defect
A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden.
- Trial name
- NCT07273227
- Testing
- Mobile Surgical Vehicle Echocardiography-guided ASD closure Group, Conventional Operating Room Echocardiography-guided ASD closure Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Atrial Septal Defect, Ventricular Septal Defect
Regional Anesthesia Following Pediatric Cardiac Surgery
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural
- Trial name
- NCT05688670
- Testing
- Regional Anesthesia, Wound infiltration, Ropivacaine 0.2% Injectable Solution
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Duke University
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
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 (ASD)
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
The objective of this PMCF study is to: confirm the safety and performance of the AcuMarkTM Sizing Balloon identify previously unknown side-effects monitor the identified side-effects (related to the procedure or to the medical…
- Trial name
- NCT06700174
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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 (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
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