AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol (ACPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01786486
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
St. Jude Medical

January 29, 2013
February 8, 2013
September 20, 2016
August 2009
December 2013   (Final data collection date for primary outcome measure)
  • 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).
  • 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
Same as current
Complete list of historical versions of study NCT01786486 on Archive Site
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AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
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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.
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Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
4 Years
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Non-Probability Sample
Patients with non-valvular atrial fibrillation
  • Atrial Fibrillation
  • Left Atrial Appendage
  • Stroke
Device: Amplatzer Cardiac Plug
Delivery system entry
Intervention: Device: Amplatzer Cardiac Plug
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2014
December 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Ireland,   Spain,   United Kingdom
Not Provided
Plan to Share IPD: Yes
Plan Description: Manuscript has been submitted to Euro Intervention Sept 2016
St. Jude Medical
St. Jude Medical
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Not Provided
St. Jude Medical
September 2016