[Trial of device that is not approved or cleared by the U.S. FDA]

Withheld

Phase N/A Results N/A

Update History

25 Jan '14
Trial name was updated.
New
[Trial of device that is not approved or cleared by the U.S. FDA]
brief_summary not implemented.gender not implemented.minimum_age not implemented.eligibility_criteria not implemented.
5 Nov '13
A location was updated in Huntsville.
New
The overall status was updated to "Withdrawn" at Huntsville Hospital / Heart Center Research LLC.
A location was updated in Los Angeles.
New
The overall status was updated to "Recruiting" at Cedars-Sinai Medical Center.
A location was updated in Littleton.
New
The overall status was updated to "Recruiting" at South Denver Cardiology Associates.
A location was updated in Columbus.
New
The overall status was updated to "Withdrawn" at The Ohio State University.
5 Apr '13
A location was updated in York.
New
The overall status was updated to "Recruiting" at York Hospital.
31 Jan '13
The Summary of Purpose was updated.
New
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.
Old
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.
Trial was updated to "N/A."
The eligibility criteria were updated.
New
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
Old
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
A location was updated in Los Angeles.
New
The overall status was updated to "Active, not recruiting" at Good Samaritan Hospital.
A location was updated in Los Angeles.
New
The overall status was updated to "Recruiting" at Cedars-Sinai Medical Center.
A location was updated in Aurora.
New
The overall status was updated to "Active, not recruiting" at University of Colorado Denver.
A location was updated in Littleton.
New
The overall status was updated to "Recruiting" at South Denver Cardiology Associates.
A location was updated in Iowa City.
New
The overall status was updated to "Active, not recruiting" at University of Iowa Hospitals & Clinics.
A location was updated in Lexington.
New
The overall status was updated to "Active, not recruiting" at University of Kentucky.
A location was updated in Philadelphia.
New
The overall status was updated to "Active, not recruiting" at University of Pennsylvania.
A location was updated in York.
New
The overall status was updated to "Recruiting" at York Hospital.
6 Oct '11
The eligibility criteria were updated.
New
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
Old
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