Overview

This trial is active, not recruiting.

Condition patent ductus arteriosus
Treatment amplatzer duct occluder ii
Sponsor St. Jude Medical
Start date August 2008
End date October 2011
Trial size 192 participants
Trial identifier NCT00713700, CL00233

Summary

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
amplatzer duct occluder ii
AMPLATZER Duct Occluder II

Primary Outcomes

Measure
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 Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
time frame: 180 days

Eligibility Criteria

Male or female participants from 6 months up to 18 years old.

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.

Additional Information

Official title Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.