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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AtriCure, Inc.

Additional 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
Study First Received: December 3, 2007
Last Updated: February 12, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on June 13, 2013