Clinical trial NCT01786486: AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Left Atrial Appendage
Stroke
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 204
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: Patients with non-valvular atrial fibrillation

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.


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
* 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)

Primary outcomes:
measure: The rate of occurrence for any reported adverse event experienced by subjects enrolled.
timeFrame: Through 2 years
measure: Closure
timeFrame: 6 months
measure: Technical success
timeFrame: At implant
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Hospital Na Homolce Cardiocentrum
city: Bonn
country: Germany
facility: St. Marien-Hospital Bonn
city: Bonn
country: Germany
facility: University of Bonn
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt
city: Frankfurt
country: Germany
facility: Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
city: Goettingen
country: Germany
facility: University Medicine Goettingen
city: Hamburg
country: Germany
facility: Asklepios Kliniken GmbH/Asklepios Klinik Harburg
city: Pirmasens
country: Germany
facility: Stadt Krankenhaus Pirmasens gGmbh
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital Universitario 'Virgen de la Arrixaca"
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital-UK
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
References: