AMPLATZER Duct Occluder II Clinical Study - Full Text View

Sponsor:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00713700

Purpose

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

Condition	Intervention
Patent Ductus Arteriosus	Device: AMPLATZER Duct Occluder II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

The primary safety endpoint will be the rate of SAE 180 days post procedure. The primary effectiveness endpoint will be the rate of complete closure of the ductus arteriosus at the six-month follow-up. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	192
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Device	Device: AMPLATZER Duct Occluder II AMPLATZER Duct Occluder II

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713700

Sponsors and Collaborators

AGA Medical Corporation

More Information

No publications provided

Responsible Party:	Karen A. Cook, AGA Medical LLC
ClinicalTrials.gov Identifier:	NCT00713700 History of Changes
Other Study ID Numbers:	CL00233
Study First Received:	July 9, 2008
Last Updated:	May 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

patent ductus arteriosus
PDA

Additional relevant MeSH terms:

Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 09, 2012