Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2020
Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03055858 (AMPLATZER Duct Occluder II Additional Sizes Clinical Study), which is not on this map. Cited by 85 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
AMPLATZER Duct Occluder II Additional Sizes Clinical Study
Who cites it
85 citing papers in PubMed, 164 citations in OpenAlex.
- Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2020Trial
- Percutaneous Pulmonary Artery Banding and Duct Occlusion in a Low-Birth-Weight Preterm Infant.JACC. Case reports · 2026Article
- Expert consensus on bedside transcatheter closure of patent ductus arteriosus in extremely low birth weight infants.Pediatric research · 2026Article
- Cardiac Interventions in Neonates: State of the Art.Indian journal of pediatrics · 2026Review
- Frequency and outcomes of surgical and transcatheter closure of patent ductus arteriosus in preterm infants in Germany-a prospective nationwide hospital-based surveillance study.European journal of pediatrics · 2026Article
- Article
- Safety and Effectiveness of the KA Micro Plug for Treatment of Patent Ductus Arteriosus in Preterm Low-Birth-Weight Infants: Retrospective Analysis From a Multicenter Registry.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus.Pediatric cardiology · 2026Article
- Effect of Transcatheter Closure of the Ductus Arteriosus on Right Ventricular Function in Preterm Neonates.Pediatric cardiology · 2026Article
- Largest Single-Center Experience Using the Micro Vascular Plug (MVP) for Transcatheter Closure of Premature Patent Ductus Arteriosus.Pediatric cardiology · 2026Review
- Impact of PDA Closure Methodology on Peri-procedural Opioid Utilization in Preterm Neonates, a Cross-Sectional Review in a Tertiary Pediatric Healthcare System.Pediatric cardiology · 2026Article
- Favorable Procedural Outcomes in Lower Versus Higher Weight Premature Infants Undergoing Transcatheter Patent Ductus Arteriosus Closure.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Echocardiographic Predictors and Incidence of Left Ventricular Dysfunction Following Transcatheter Patent Ductus Arteriosus Closure in Extremely Premature Infants.Pediatric cardiology · 2026Article
- Patent Ductus Arteriosus Morphology Changes in Preterm Neonates Undergoing Transcatheter Device Closure.Pediatric cardiology · 2026Article
- Factors associated with procedural difficulty and major adverse events during transcatheter closure of the patent ductus arteriosus.PloS one · 2026Article
- Comment On: Piccolo Device for Treating Patent Ductus Arteriosus Beyond Premature Newborn Patients, a Novel Experience in South America: A Retrospective Study.Health science reports · 2026Article
- Suspected Infective Endocarditis in a Premature Neonate After Patent Ductus Arteriosus Occluder Placement: A Case Report.Case reports in pediatrics · 2026Article
- Complications of Interventional Versus Surgical Closure of Patent Ductus Arteriosus in Very Preterm Infants-A Retrospective Analysis.Journal of cardiovascular development and disease · 2025Article
- Management of the patent ductus arteriosus among infants born at 23 to 32 weeks' gestation between 2011 to 2022: a report from in the Children's Hospitals Neonatal Consortium.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Feasibility and Safety of Percutaneous Device Closure of Patent Ductus Arteriosus in Preterm Neonates: Experience From a Single Center in Northern India.Indian pediatrics · 2025Article
25 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesCharacterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure.
backgroundThe presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature.
methodsThis was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up.
resultsThe implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g.
conclusionsThis study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.