Clinical trial NCT01118299: AMPLATZER Cardiac Plug Clinical Trial
Official title: Amplatzer Cardiac Plug Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Ischemic Stroke
Peripheral Thromboembolism
Keywords: ACP
Atrial Fibrillation
AF
A Fib
Stroke
Coumadin
Warfarin
Dabigatran
Pradaxa
Blood thinning medication
Left atrial appendage
LAA
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.


Eligibility 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 or dabigatran therapy
* Subject must be eligible for long term warfarin or dabigatran therapy
* Subject must have a CHADS(2) score of 2 or greater

Summary of Exclusion Criteria:

* Subject who requires warfarin or dabigatran for a condition other than AF
* Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
* Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
* Subject with a New York Heart Association (NYHA) classification equal to IV
* Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
* Subject with aortic or mitral valve regurgitation of grade 2+ or greater
* 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
* Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
* Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment

Primary outcomes:
measure: Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
timeFrame: From Randomization to Discharge Visit
measure: Long-term Safety - Device Arm Only
timeFrame: Randomization to 2 year follow-up
measure: Effectiveness Endpoint - Device Arm Only
timeFrame: Randomization through 2 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Atlanta
country: United States
facility: Emory Midtown Hospital and Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital and Research Institute
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Saint Cloud
country: United States
facility: St. Cloud Hospital/CentraCare Heart and Vascular Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital/PMG Research of Charleston
state: South Carolina
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Wausau
country: United States
facility: Aspirus Heart & Vascular Institute
state: Wisconsin
Study officials:
References: