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Safety and Effectiveness of Left Atrial Appendage Occlusion

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ClinicalTrials.gov Identifier: NCT00567515
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: AtriCure LAA Exclusion System Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAA Clip
AtriCure LAA Exclusion System
Device: AtriCure LAA Exclusion System
Placement of clip of LAA.




Primary Outcome Measures :
  1. Safety - Device related complications [ Time Frame: 30 days ]
  2. Efficacy - Occlusion of the LAA [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00567515


Locations
Switzerland
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Michele Genoni, MD, Professor University of Zurich