Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams

Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20.


Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure.

Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature.

Methods: This 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.

Results: The 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.

Conclusions: This 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. identifier: NCT03055858.

Keywords: ADO II AS; Amplatzer Piccolo Occluder; FDA; patent ductus arteriosus; prematurity; transcatheter closure.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Birth Weight
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Coronary Circulation
  • Ductus Arteriosus, Patent / diagnostic imaging
  • Ductus Arteriosus, Patent / physiopathology
  • Ductus Arteriosus, Patent / therapy*
  • Female
  • Gestational Age
  • Hemodynamics
  • Humans
  • Infant, Extremely Premature*
  • Infant, Newborn
  • Infant, Very Low Birth Weight*
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Septal Occluder Device*
  • Time Factors
  • Treatment Outcome
  • United States

Associated data