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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)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT00841529
First received: February 10, 2009
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Complete occlusion of the left atrial appendage [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841529

Locations
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
Investigators
Study Chair: Patrick McCarthy, MD Northwestern University
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00841529     History of Changes
Other Study ID Numbers: D02940
Study First Received: February 10, 2009
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Medtronic Cardiovascular:
left atrial appendage
LAA
atrial fibrillation
AF

ClinicalTrials.gov processed this record on May 19, 2013