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

ABSTRACT:

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 o

SUBMITTER: Sathanandam SK 

PROVIDER: S-EPMC7754477 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature