Clinical trials: Cardiac Defect
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
Congenital Heart Defect
Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.
Surgeries of heart disease in adulthood can happen in two specific contexts: either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in life and tardily diagnosed and surgically managed either for a…
- Trial name
- NCT03063801
- Testing
- Data extraction in medical files
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- Pierre Wauthy
Muscular Ventricular Septal Defect
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- Trial name
- mVSD Registry (NCT05329350)
- Testing
- Occlutech muscular ventricular septal defect (mVSD) Occluder
- Where
- 6 sites in Ireland, Turkey (Türkiye) and 1 more
- Volunteers
- 50 people
- Sponsor
- Occlutech International AB
Perimembranous Ventricular Septal Defect
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult…
- Trial name
- PERI-CLOSE (NCT06823635)
- Testing
- Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
- Where
- 25 sites in Denmark, Egypt and 15 more
- Volunteers
- 2,000 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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
Single Ventricle Defect
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
This study seeks to determine cerebral blood flow changes in single ventricle patients during staged surgical reconstruction as compared with normal children.
- Trial name
- CBF (NCT02135081)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Heart Defect, Blood Coagulation Disorder
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).
- Trial name
- POCHEMO (NCT02387944)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
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.
Congenital Heart Defect, Respiratory Distress Syndrome in Premature Infant
Neonatal Cardio-Pulmonary Outcome Measure
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU).
- Trial name
- N-COM (NCT04324957)
- Testing
- Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Asir John Samuel
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD)…
- Conditions
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications
- Trial name
- NCT07375602
- Where
- China
- Volunteers
- 5,249 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease
Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays.
- Trial name
- NCT00556231
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Medical College of Wisconsin
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
Atrial Septal Defect
Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect.
- Trial name
- NCT06139679
- Testing
- ASD closure with fenestrated/non-fenestrated patch
- Where
- Indonesia
- Volunteers
- 21 people
- Sponsor
- Dr. Soetomo General Hospital
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.
Congenital Heart Disease, Cardiopulmonary Bypass
Acetaminophen for Oxidative Stress After Cardiopulmonary Bypass
The current proposal tests the central hypothesis that acetaminophen will attenuate the oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in children undergoing cardiac surgery.
- Trial name
- NCT01228305
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt University Medical Center
Heart Septal Defects, Ventricular
Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed.
- Trial name
- pfm-01/2005 (NCT00390702)
- Testing
- transcatheter implantation of a VSD occluder (Nitinol coil)
- Where
- 6 sites in Germany, Israel
- Volunteers
- 103 people
- Sponsor
- pfm medical gmbh
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
Congenital Heart Disease
Critical Congenital Heart Defect (CHD) Outcomes in Children
Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions.
- Trial name
- NCT00208689
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Emory University
Congenital Heart Defect, Right Ventricular Outflow Tract Reconstruction
Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns
Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed…
- Trial name
- NCT03348397
- Testing
- right ventricular outflow tract reconstruction with contegra, right ventricular outflow tract reconstruction with pulmonary homograft
- Where
- Belgium
- Volunteers
- 53 people
- Sponsor
- Queen Fabiola Children's University Hospital
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs