Phase 3 N=44 The Effects of Inhaled Nitric Oxide After Fontan Operation
Congenital Heart Defect
Primary: Length of Hospital Stay Following Fontan — 11.2; 11 days
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=5 Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
Heart Defects, Congenital
Primary: The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. — 0 Participants
Phase 3 N=12 Use of Vasopressin Following the Fontan Operation
Pleural Effusion · Single-ventricle
Primary: Chest Tube Drainage — 686.83; 535.50 ml/kg
Phase 2 N=28 Sildenafil After the Fontan Operation
Hypoplastic Left Heart Syndrome · Tricuspid Atresia
Primary: Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks — 30.5; 30.5; 31.3; 31.3 mL/kg/min — p=0.73
Phase 4 N=26 Effect of Carvedilol on Exercise Performance in Fontan Patients
Single Ventricle · Fontan
Primary: Change in Peak Oxygen Uptake From Baseline Peak Oxygen Uptake — -2.01; -1.01 ml/kg/min
Phase 3 N=137 Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Congenital Heart Disease
Primary: Change From Baseline in Peak Oxygen Uptake/Consumption (VO2) Up to Week 16 — -0.67; -0.16 Milliliter/kilogram/minute (mL/kg/min) — p== 0.1930
N/A N=555 Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Heart Defects, Congenital
Primary: Proportion of Patients Who Died or Received a Heart Transplant — 100; 72 Participants — p=0.013
N/A N=21 Stage 3 Fontan Operation Liver Ultrasound Study
Fontan Operation
Primary: Shear Wave Speed (Liver Stiffness) — 1.18; 2.28; 2.22; 2.08 meters per second — p=<0.0001
Phase 2 N=16 Ambrisentan in Single Ventricle
Hypoplastic Left Heart Syndrome · Hypoplastic Right-sided Heart Complex
Primary: Area Under the Curve for Ambrisentan Plasma Concentration — 7871.46 ng*hr/mL
Phase 1 N=14 Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic Left Heart Syndrome · Single Ventricle · Heart Failure
Primary: Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells — 0; 0 participants
N/A N=14 Modified Perfusion for Neonatal Aortic Arch Reconstruction
Aortic Arch Hypoplasia or Atresia
Primary: Intestinal Fatty Acid Binding Protein and C-reactive Protein
Phase 4 N=16 The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Fontan Circulation
Primary: The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) — 39.4; 36.8; 41.2; 34.4 ml/min/kg
Phase 4 N=28 The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Single Ventricle Fontan Palliation
Primary: Change in VO2 Max — 1.33; 0.745 Change in ml/kg min
N/A N=12 Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
Congenital Heart Disease · Single Ventricle
Primary: Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements. — 24.0 ml/kg/min — p=0.1673
N/A N=15 Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Single-ventricle
Primary: Change in Pulmonary Pulsatility Index — 51.6; 57.6 Ratio — p=0.1
Phase 4 N=20 Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Single Ventricle Heart Disease After Fontan Surgery
Primary: End-systolic Elastance — 0.85; 1.8 Ees in mmHg/ml/m2
Phase 3 N=20 Early Use of Vasopressin in Post-Fontan Management
Circulatory Perfusion Disorder · Congenital Heart Disease · Single-ventricle
Primary: Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS) — 11; 11.3 units
N/A N=140 A New Operation for the Treatment for Long-standing Atrial Fibrillation
Cardiovascular Disease
Primary: Numbers of Participants Free From AF — 20; 96; 20; 97 Participants
Phase 3 N=400 Fontan Udenafil Exercise Longitudinal Assessment Trial
Single Ventricle Heart Disease
Primary: Change in Maximal VO2 From Baseline to Week 26 Using Last Observation Carried Forward (LOCF) — -0.23; -0.89 mL/kg/min — p=0.092
N/A N=22 Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Hypoplastic Left Heart Syndrome
Primary: Time to First Post-operative Negative 24 Hour Fluid Balance — 2.7; 2.67 Days
N/A N=5 Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Heart Defects, Congenital
Primary: The Number of Patch Related Serious Adverse Events. — 0 Participants
Phase 2 N=5 'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
Hernia · Hernia, Diaphragmatic · Hernia, DIaphragmatic, Congenital
Primary: Proportion of Neonate Survival at Discharge From Hospital — 1; 3 Participants
Phase 3 N=20 Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
Cirrhosis · Congenital Heart Disease
Primary: Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) — 5.69; 5.72; 5.02; 5.68 kPa
Phase 1 N=21 Sildenafil in Single Ventricle Patients
Heart Disease
Primary: Maximum Sildenafil Plasma Concentration — 181; 515; 545; 202 ng/mL
N/A N=50 Pulmonary Artery Repair With Covered Stents
Pulmonary Stenosis · Pulmonary Regurgitation · Tetralogy of Fallot
Primary: Successful Repair of Conduit Disruption — 48 participants
N/A N=34 Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Congenital Heart Defects
Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2
N/A N=61 Cardioband With Transfemoral Delivery System
Mitral Regurgitation
Primary: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects — 2; 1; 2; 4 Participants
Phase 1 N=25 The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
Hypoplastic Left Heart Syndrome
Primary: Number of Incidence of Treatment Related Major Adverse Cardiac Events — 1; 0; 6 Events
N/A N=81 COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Pulmonary Valve Insufficiency · Pulmonary Regurgitation · Dysfunctional RVOT Conduit
Primary: Freedom From Device or Procedure Related Death or Reintervention — 97.1 percentage of participants
N/A N=89 Pediatric Cardiac Output Monitoring Observational Study
Pediatric ALL
Primary: Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output — 0.49 L/min