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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT01786486
First received: January 29, 2013
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention
Atrial Fibrillation
Left Atrial Appendage
Stroke
Device: Amplatzer Cardiac Plug

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • The rate of occurrence for any reported adverse event experienced by subjects enrolled. [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]
  • Closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 204
Study Start Date: August 2009
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Delivery system entry Device: Amplatzer Cardiac Plug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-valvular atrial fibrillation

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786486

Locations
Czech Republic
Hospital Na Homolce Cardiocentrum
Prague, Czech Republic
Germany
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
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Spain
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
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT01786486     History of Changes
Other Study ID Numbers: CL03562
Study First Received: January 29, 2013
Last Updated: January 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Comité Ético de Investigación Clínica
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Medical Ethics Research Committee
Czech Republic: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014