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

January 29, 2013
January 24, 2014
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 ] [ 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
Same as current
Complete list of historical versions of study NCT01786486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
Not Provided

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.

Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
4 Years
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
Not Provided
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Ireland,   Spain,   United Kingdom
 
NCT01786486
CL03562
Yes
AGA Medical Corporation
AGA Medical Corporation
Not Provided
Not Provided
AGA Medical Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP