Clinical trial NCT01962051: AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
Official title: AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Left Atrial Appendage
Stroke
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with nonvalvular atrial fibrillation (NVAF)

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


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
* 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)

Primary outcomes:
measure: Evaluate the performance of the ACP device in closure of the LAA
timeFrame: 2 years post implant
measure: The rate of occurrence for any reported adverse event experienced by subjects enrolled
timeFrame: Through 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: