Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

This study is ongoing, but not recruiting participants.

First Received: December 20, 2007 Last Updated: December 21, 2007 History of Changes

Sponsored by:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00583596

Purpose

The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.

Condition	Intervention
Patent Ductus Arteriosus PDA	Device: Device closure with AMPLATZER Duct Occluder Other: Objective Performance Criteria

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The residual patency rate is expected to be < 15% by Doppler color flow mapping and <5% by clinical exam. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	441
Study Start Date:	October 1999
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Device closure with AMPLATZER Duct Occluder Device closure with AMPLATZER Duct Occluder
2	Other: Objective Performance Criteria Compare results of device closure to objective performance criteria

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a demonstrated patent ductus arteriosus
Body weight > 5 Kilograms

Exclusion Criteria:

Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4.
Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
Pelvic vein or inferior vena cava thrombosis
Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
History of repeated pulmonary infection
Demonstrated intracardiac thrombi on echocardiography
- Inability to obtain informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583596

Show 24 Study Locations

Sponsors and Collaborators

AGA Medical Corporation

More Information

Additional Information:

FDA Approval Order This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AGA Medical Corporation ( Tammy Benson )
Study ID Numbers:	AGA-004, G980103
Study First Received:	December 20, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00583596 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

patent
ductus
arteriosus
PDA

Study placed in the following topic categories:

Heart Diseases
Patent Ductus Arteriosus
Cardiovascular Abnormalities

Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

ClinicalTrials.gov processed this record on September 10, 2009