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

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Left Atrial Appendage Stroke Device: Amplatzer Cardiac Plug

Study Type : Observational [Patient Registry]
Actual Enrollment : 204 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Study Start Date : August 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Delivery system entry Device: Amplatzer Cardiac Plug

Primary Outcome Measures :
  1. The rate of occurrence for any reported adverse event experienced by subjects enrolled. [ Time Frame: Through 2 years ]
  2. 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).

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01786486

Czech Republic
Hospital Na Homolce Cardiocentrum
Prague, Czech Republic
St. Marien-Hospital Bonn
Bonn, Germany
University of Bonn
Bonn, Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany
Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
Frankfurt, Germany
University Medicine Goettingen
Goettingen, Germany
Asklepios Kliniken GmbH/Asklepios Klinik Harburg
Hamburg, Germany
Stadt Krankenhaus Pirmasens gGmbh
Pirmasens, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
Hospital Universitario Infanta Cristina
Badajoz, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario 'Virgen de la Arrixaca"
Murcia, Spain
Hospital de Navarra
Pamplona, Spain
United Kingdom
Royal Sussex County Hospital-UK
Brighton, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT01786486     History of Changes
Other Study ID Numbers: CL03562
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Manuscript has been submitted to Euro Intervention Sept 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes