Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

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. Identifier: NCT00841529
Recruitment Status : Terminated (Medtronic Business Decision)
First Posted : February 11, 2009
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA

Condition or disease Intervention/treatment Phase
Left Atrial Appendage Occlusion Device: Medtronic LAA Occlusion Device Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 2010

Intervention Details:
    Device: Medtronic LAA Occlusion Device
    Placement of the occlusion band on the LAA
    Other Name: Medtronic Cardioblate Closure Left Atrial Appendage Occlusion Device

Primary Outcome Measures :
  1. Complete occlusion of the left atrial appendage [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. To evaluate the composite incidence rate of device-related adverse events [ Time Frame: Discharge/30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
  • Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
  • The subject is willing and able to provide written informed consent and comply with study requirements
  • The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)

Exclusion Criteria:

  • Thrombus in the LAA and/or left atrium
  • Prior LAA isolation attempts
  • Subject is unable to take an anticoagulant during the study follow-up period
  • Subject is undergoing an emergency cardiac procedure
  • Life expectancy of less than 12 months
  • Pregnancy or desire to be pregnant within the 12 months of the study procedure

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 identifier (NCT number): NCT00841529

United States, California
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Medtronic Cardiovascular
Study Chair: Patrick McCarthy, MD Northwestern University

Responsible Party: Medtronic Cardiovascular Identifier: NCT00841529     History of Changes
Other Study ID Numbers: D02940
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Medtronic Cardiovascular:
left atrial appendage
atrial fibrillation