AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational

Withdrawn

• Conditions: Stroke; Left Atrial Appendage; Atrial Fibrillation
• Interventions: Device: Amplatzer Cardiac Plug

• Registration Number: NCT01962051
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
• 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 3 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 example uncontrolled hypertension, uncontrolled diabetes, blood disorder, renal failure, in situ IVC filter)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delivery system Entry	Amplatzer Cardiac Plug	-

Primary Outcome Measures

Name	Time	Method
Evaluate the performance of the ACP device in closure of the LAA	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	Through 2 years