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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.
December 3, 2007
December 5, 2007
February 13, 2013
September 2007
July 2010   (Final data collection date for primary outcome measure)
  • Safety - Device related complications [ Time Frame: 30 days ]
  • Efficacy - Occlusion of the LAA [ Time Frame: 6 months ]
  • Safety - Device related complications [ Time Frame: 3 Months ]
  • Efficacy - Occlusion of the LAA [ Time Frame: 3 Months ]
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
Intervention Model: Single Group Assignment
Masking: None (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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00567515
OUS 2007-1
Yes
Not Provided
Not Provided
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