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

This study has been terminated.
(Medtronic Business Decision)
Information provided by (Responsible Party):
Medtronic Cardiovascular Identifier:
First received: February 10, 2009
Last updated: October 18, 2012
Last verified: October 2012
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA

Condition Intervention Phase
Left Atrial Appendage Occlusion Device: Medtronic LAA Occlusion Device Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Medtronic Cardiovascular:

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

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

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Medtronic Cardiovascular Identifier: NCT00841529     History of Changes
Other Study ID Numbers: D02940
Study First Received: February 10, 2009
Last Updated: October 18, 2012

Keywords provided by Medtronic Cardiovascular:
left atrial appendage
atrial fibrillation
AF processed this record on August 23, 2017