Clinical trials: Patent Ductus Arteriosus
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Additional Sizes
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA).
- Trial name
- ADO II AS (NCT03055858)
- Testing
- ADO II AS (PDA closure)
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Clinical Study
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
- Trial name
- ADO II (NCT00713700)
- Testing
- AMPLATZER Duct Occluder II
- Where
- 25 sites in United States
- Volunteers
- 192 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA).
- Trial name
- PIVOTAL (NCT03982342)
- Testing
- Cather closure of patent ductus arteriosus (PDA), Conservative management of patent ductus arteriosus (PDA)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Nationwide Children's Hospital
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Patent Ductus Arteriosus, Surgery
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach.
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Trial name
- PDA:TOLERATE (NCT01958320)
- Testing
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- Where
- 18 sites in United States, Sweden and 2 more
- Volunteers
- 202 people
- Sponsor
- University of California, San Francisco
Patent Ductus Arteriosus, Preterm Infant
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing…
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia
- Trial name
- NCT03701074
- Testing
- Ibuprofen and acetaminophen
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of South Alabama
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one…
- Trial name
- Fenaki (NCT02620761)
- Testing
- Fenoldopam, 0.9%NS
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
Patent Ductus Arteriosus
Timing of PDA Closure and Respiratory Outcome in Premature Infants
The investigators propose the present study with the following aims: to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen…
- Trial name
- NCT00802685
- Testing
- Early ibuprofen
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of Miami
Patent Ductus Arteriosus
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
This is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and provided a description of the study.
- Trial name
- NCT01790750
- Testing
- PES first, then FFES
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Florida
Patent Ductus Arteriosus, Prematurity
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of…
- Trial name
- NCT00833365
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Patent Ductus Arteriosus (PDA)
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
- Trial name
- NCT00583596
- Testing
- Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
- Where
- 24 sites in United States
- Volunteers
- 436 people
- Sponsor
- Abbott Medical Devices
Infant, Premature, Patent Ductus Arteriosus
Management of the PDA Trial
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
- Conditions
- Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
- Trial name
- PDA (NCT03456336)
- Testing
- Active Treatment, Expectant Management
- Where
- 19 sites in United States
- Volunteers
- 482 people
- Sponsor
- NICHD Neonatal Research Network
Congenital Heart Disease
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
- Trial name
- NCT01063712
- Testing
- Nit-Occlud® PDA-R
- Where
- Bolivia
- Volunteers
- 29 people
- Sponsor
- pfm S.R.L.