AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Abbott Medical Devices
- Enrollment
- 204
- Locations
- 15
- Primary Endpoint
- Technical success
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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 be ≥18 years of age
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Technical success
Time Frame: At implant
Defined as delivery and release of the ACP device, including recapture and/or replacement, as necessary. This success will be calculated among subjects in whom the device enters the body
The rate of occurrence for any reported adverse event experienced by subjects enrolled.
Time Frame: Through 2 years
Closure
Time Frame: 6 months
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at six (6) months as assessed by Transoesophageal Echocardiography (TOE).