Clinical trials: Atrial Septal Defect (ASD)
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
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
Congenital Disorders
Pulmonary Hypertension in Trisomy 21 Patients
Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect.
- Trial name
- NCT00478296
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Healthcare of Atlanta
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, 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
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
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
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
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
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
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
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
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
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
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
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.
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.
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
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
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.