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

Left Atrial Appendage Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00841529
• Other study ID #: D02940
• Status: Terminated
• Phase: Phase 2
• First received: February 10, 2009
• Last updated: October 18, 2012
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2012
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Left Atrial Appendage Occlusion

Intervention

Device:
• Medtronic LAA Occlusion Device
Placement of the occlusion band on the LAA

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Eisenhower Medical Center	Rancho Mirage	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete occlusion of the left atrial appendage		3 Months	No
Secondary	To evaluate the composite incidence rate of device-related adverse events		Discharge/30 days	Yes