AMPLATZER Cardiac Plug Clinical Trial - Full Text View

Sponsor:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT01118299

Purpose

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation compared to standard of care medical therapy-warfarin.

Condition	Intervention	Phase
Atrial Fibrillation	Device: AMPLATZER Cardiac Plug	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

45 Day Serious Adverse Event Rate [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
the 45 day results in the first 30 subjects who receive the device or who undergo an implant attempt

Estimated Enrollment:	45
Study Start Date:	May 2010
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Device AMPLATZER Cardiac Plug	Device: AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Active Comparator: Warfarin Warfarin Drug	Device: AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
Subject must be ≥18 years of age
Subject must be on warfarin therapy
Subject must be eligible for long term warfarin therapy
Subject must have a CHADS(2) score of 2 or greater

Exclusion Criteria:

Subject who requires warfarin for a condition other than AF
Subject who has an absolute or relative contraindication to aspirin, or warfarin
Subject with a New York Heart Association (NYHA) classification equal to IV
Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
Subject with left ventricular ejection fraction (LVEF) ≤30
Subject with mitral or aortic prosthetic valve
Subject with a history of hemorrhagic or aneurysmal stroke
Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
Subject with a body mass index (BMI) ≥40

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118299

Locations

United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
South Denver Cardiology Associates
Littleton, Colorado, United States, 80120
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6006
York Hospital
York, Pennsylvania, United States, 17405

Sponsors and Collaborators

AGA Medical Corporation

More Information

Additional Information:

Atrial Fibrillation Tutorial This link exits the ClinicalTrials.gov site

Overview of Atrial Fibrillation This link exits the ClinicalTrials.gov site

Stroke 101 - Fact Sheet This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pam Simons/Vice President of Clinical and Regulatory Affairs, AGA Medical LLC
ClinicalTrials.gov Identifier:	NCT01118299 History of Changes
Other Study ID Numbers:	CL00921
Study First Received:	May 5, 2010
Last Updated:	March 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

ACP
Atrial Fibrillation
AF
A Fib
Stroke

Coumadin
Warfarin
Blood thinning medication
Left atrial appendage
LAA

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012