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Safety and Effectiveness of Left Atrial Appendage Occlusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567515
First Posted: December 5, 2007
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AtriCure, Inc.
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00567515     History of Changes
Other Study ID Numbers: OUS 2007-1
First Submitted: December 3, 2007
First Posted: December 5, 2007
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes