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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

February 10, 2009
October 18, 2012
March 2009
November 2009   (final data collection date for primary outcome measure)
Complete occlusion of the left atrial appendage [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841529 on ClinicalTrials.gov Archive Site
To evaluate the composite incidence rate of device-related adverse events [ Time Frame: Discharge/30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Left Atrial Appendage Occlusion
Device: Medtronic LAA Occlusion Device
Placement of the occlusion band on the LAA
Other Name: Medtronic Cardioblate Closure Left Atrial Appendage Occlusion Device
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841529
D02940
Yes
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Study Chair: Patrick McCarthy, MD Northwestern University
Medtronic Cardiovascular
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP