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Safety and Effectiveness of Left Atrial Appendage Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00567515
First received: December 3, 2007
Last updated: February 12, 2013
Last verified: February 2013
History of Changes

December 3, 2007
February 12, 2013
September 2007
July 2010   (final data collection date for primary outcome measure)
  • Safety - Device related complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Efficacy - Occlusion of the LAA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety - Device related complications [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
  • Efficacy - Occlusion of the LAA [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00567515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness of Left Atrial Appendage Occlusion
Not Provided

This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: AtriCure LAA Exclusion System
Placement of clip of LAA.
Experimental: LAA Clip
AtriCure LAA Exclusion System
Intervention: Device: AtriCure LAA Exclusion System
Salzberg SP, Plass A, Emmert MY, Desbiolles L, Alkadhi H, Grünenfelder J, Genoni M. Left atrial appendage clip occlusion: early clinical results. J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. Epub 2009 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
November 2012
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Documented history (paroxysmal, persistent or permanent) of AF [one episode within the last 12 months of enrollment]
  2. Elective Maze procedure
  3. Suitable anatomy
  4. Able and willing to sign informed consent
  5. Age over 18 years

Exclusion Criteria:

  1. Patient from Intensive Care Unit with either:

    1. intra-venous catecholamines
    2. ventilator
    3. cardiac index <1.8 l/min.
  2. Reoperative Cardiac Surgery
  3. Systemic or Inflammatory disease
  4. Dialysis
  5. Recent myocardial infarction (< 21 days)
  6. History of pericarditis
  7. Patient taking part in any other device or drug study
  8. Patient with known sensitivity or allergy to any of the device components
  9. Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00567515
OUS 2007-1
Yes
AtriCure, Inc.
AtriCure, Inc.
Not Provided
Principal Investigator: Michele Genoni, MD, Professor University of Zurich
AtriCure, Inc.
February 2013

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