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Safety and Effectiveness of Left Atrial Appendage Occlusion

This study has been completed.
Information provided by (Responsible Party):
AtriCure, Inc. Identifier:
First received: December 3, 2007
Last updated: February 12, 2013
Last verified: February 2013
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 Intervention Phase
Atrial Fibrillation Device: AtriCure LAA Exclusion System Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by AtriCure, Inc.:

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

Enrollment: 41
Study Start Date: September 2007
Study Completion Date: November 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAA Clip
AtriCure LAA Exclusion System
Device: AtriCure LAA Exclusion System
Placement of clip of LAA.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00567515

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AtriCure, Inc. Identifier: NCT00567515     History of Changes
Other Study ID Numbers: OUS 2007-1
Study First Received: December 3, 2007
Last Updated: February 12, 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 25, 2017