AMPLATZER Cardiac Plug Clinical Trial

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism

In brief

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.

Key facts

Study ID

NCT01118299

Run by

Abbott Medical Devices

People needed

97

Starts

2010-04-26

Expected to finish

2018-12-06

Last updated by the study team

2020-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Good Samaritan Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Emory Midtown Hospital and Emory University Hospital — Atlanta, Georgia, United States
• St. Joseph's Hospital and Research Institute — Atlanta, Georgia, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Providence Hospital — Southfield, Michigan, United States
• St. Cloud Hospital/CentraCare Heart and Vascular Clinic — Saint Cloud, Minnesota, United States
• HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• York Hospital — York, Pennsylvania, United States
• Roper Hospital/PMG Research of Charleston — Charleston, South Carolina, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• Aspirus Heart & Vascular Institute — Wausau, Wisconsin, United States

Full record on ClinicalTrials.gov

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