NCT01962051
Withdrawn
N/A
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Abbott Medical Devices
- Primary Endpoint
- Evaluate the performance of the ACP device in closure of the LAA
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 have a LAA closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study
- •Subject must be greater than or equal to 18 years of age
Exclusion Criteria
- •Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- •Subject underwent LAA closure procedure prior to study entry (i.e. before signing informed consent
- •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 requiring surgical or percutaneous intervention as assessed by the Investigator
- •Subject who has a mitral or aortic prosthetic valve
- •Subject with NYHA grade 4
- •Subject with evidence of moderate 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
Outcomes
Primary Outcomes
Evaluate the performance of the ACP device in closure of the LAA
Time Frame: 2 years post implant
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at 6 months, 1 year and 2 years as assessed by Transoesophageal Echocardiography (TOE).
The rate of occurrence for any reported adverse event experienced by subjects enrolled
Time Frame: Through 2 years
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