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

NCT00841529 | Terminated Phase 2 DMC

• 1 other identifier: D02940
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Left Atrial Appendage Occlusion

Keywords

left atrial appendage; LAA; atrial fibrillation; AF

Outcome Measures

Primary Outcomes (1)

• Complete occlusion of the left atrial appendage

  3 Months

Secondary Outcomes (1)

• To evaluate the composite incidence rate of device-related adverse events

  Discharge/30 days

Interventions

Medtronic LAA Occlusion Device DEVICE

Placement of the occlusion band on the LAA

Also known as: Medtronic Cardioblate Closure Left Atrial Appendage Occlusion Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (5)

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick McCarthy, MD

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

US (5)