AMPLATZER Duct Occluder II Clinical Stu… | Clinical Trial

Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital and Health Center, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject must have diagnosis of a PDA
Subject must have a PDA < 5.5mm in diameter by angiography
Subject must have a PDA < 12mm in length by angiography
Subject must have a PDA > 3mm in length by angiography
Subject/legally authorized representative must give consent to participate in the clinical study
Subject/legally authorized representative must consent to follow-up for the duration of the clinical study

Exclusion criteria

Subject must not be < 6 kilograms for the procedure
Subject must not be < 6 months of age
Subject must not be ≥ 18 years of age
Subject must not have a descending aorta < 10mm in diameter
Subject must not have a right to left shunt through the patent ductus arteriosus
Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4
Subject must not have intracardiac thrombus
Subject must not have additional cardiac anomalies requiring surgical or interventional correction
Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
Subject must not have active infection requiring treatment at the time of implant
Subject must not have contraindication to anticoagulation treatment
Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant*
Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.

Treatment and study plan

AMPLATZER Duct Occluder II

Device

AMPLATZER Duct Occluder II

Primary outcomes

The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.

Time frame: 180 days

The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure

SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.

Time frame: 180 days

The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Acronym: ADO II

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2016
First posted: Jul 11, 2008
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed