N/A N=436 Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Patent Ductus Arteriosus (PDA)
Primary: Reporting of Late Adverse Events Relating to the Device. — 9 participant
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=202 Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Patent Ductus Arteriosus · Surgery · Necrotizing Enterocolitis
Primary: Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits)…
Phase 2 N=29 Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Congenital Heart Disease
Primary: Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) — 19; 23; 28; 29 Participants…
N/A N=192 AMPLATZER Duct Occluder II Clinical Study
Patent Ductus Arteriosus
Primary: The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. — 1.6 percentage of participants
N/A N=50 Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Patent Ductus Arteriosus
Primary: False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) — 10.8 percentage of…
N/A N=63 Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Foramen Ovale, Patent · Heart Catheterization · Heart Septal Defects, Atrial
Primary: Number of Participants With a Successful Implantation. — 62 participants
N/A N=200 AMPLATZER Duct Occluder II Additional Sizes
Patent Ductus Arteriosus
Primary: Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant — 0; 2.8 percentage of participants
N/A N=1,000 Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Atrial Septal Defect
Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
N/A N=980 Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Cryptogenic Stroke
Primary: Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization — 9; 16 Participants — p=0.08
N/A N=21 Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Primary: Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping — 17 Participants
N/A N=131 The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Post-Infarction Ventricular Septal Defect
Primary: Effectiveness Endpoint 1: Technical Success — 76 Participants
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=92 Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Ventricular Septal Defects
Primary: Primary Effectiveness End Point: Technical Success — 75 Participants
Phase 2 N=66 Milrinone in Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia · Persistent Pulmonary Hypertension of the Newborn · Hypoxemic Respiratory Failure
Primary: Oxygenation Response — 4.2; 2.6 Change in Oxygenation Index
Phase 3 N=311 A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Chronic Kidney Disease
Primary: Time to AVF Primary Unassisted Patency — 214; 171 Days — p=0.254
N/A N=91 Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Heart Septal Defects, Ventricular
Primary: Closure of Muscular Ventricular Septal Defects — 91 participants
N/A N=47 Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
Patent Foramen Ovale
Primary: Arterial Nitrogen Bubbles After Surfacing — 0; 6; 0; 7 participants — p=0.02
Phase 3 N=1,316 Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Infant, Newborn, Diseases · Other Preterm Infants · Infant, Small for Gestational Age
Primary: Survival Without Bronchopulmonary Dysplasia (BPD) — 346; 320 Participants
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=256 Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular Hemorrhage · Periventricular Leukomalacia · Brain Injury
Primary: Percent of Survivors With no Severe IVH (Grades 3 or 4) or PVL — 22.2; 14.9; 17.1; 10.9 percent of participants
Phase 4 N=5 Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Primary: Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio) — 0.8; 0.75; 0.61; 0.73 Rp:Rs ratio — p=0.9
Phase 2 N=106 Safety of Sildenafil in Premature Infants
Bronchopulmonary Dysplasia
Primary: Safety as Determined by Adverse Event Experienced by Participants — 71; 83; 53; 60 Events
N/A N=664 GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Stroke · Transient Ischemic Attack
Primary: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) — 6; 12 Participants — p=0.001
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
Phase 2 N=125 Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia of Newborn
Primary: Safety Based Upon Number of Participants With Hypotension — 1; 0; 0; 0 Participants
Phase 4 N=96 Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Pediatrics · Anesthesia · Vasospasm
Primary: Number of Participants With Optimal Arterial Waveform — 27; 18 Participants
N/A N=50 BPD Saturation TARgeting
Bronchopulmonary Dysplasia · Chronic Lung Disease of Prematurity · Chronic Lung Disease
Primary: Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time — 2.2; 1.2 IH events per 8 hours of monitoring time
N/A N=100 VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Renal Failure Chronic Requiring Hemodialysis · Chronic Renal Insufficiency
Primary: Primary Patency - Intervention-free Interval (Measured in Weeks) — 89.1; 95.5; 79.4; 87.2 percentage of primary patency
Phase 3 N=906 Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Heart Defects, Congenital
Primary: Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)…
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