AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol (ACPR)
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The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with non-valvular atrial fibrillation
Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ECG), Holter, or event recorder)
Subject must be ≥18 years of age
Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
Subject who has a history of surgical ASD or PFO repair
Subject with a history of stroke and unrepaired PFO
Subject who has moderate to severe aortic or mitral valve stenosis or regurgitation as assessed by the investigator
Subject who has a mitral or aortic prosthetic valve
Subject who has a planned ablation procedure for atrial fibrillation 30 days after the ACP implant
Subject with New York Heart Association (NYHA) grade 4
Subject with evidence of pericardial effusion at baseline evaluation
Subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Subject who has an intracardiac thrombus
Subject who has carotid disease as assessed by the investigator, requiring treatment, which includes revascularization and/or medical treatment
Subject with active infection or active endocarditis
Subject who has an acute or recent myocardial infarction (MI) or unstable angina (recent is defined as within 6 months of implant date)
Subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date)
Subject with malignancy or other illness where life expectancy is less than one year
Subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up
Subject or legally authorized representative who is unable to provide informed consent
Subject who will not be able to be followed for the duration of the clinical study
Subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava (IVC) filter)