Medtronic LAA Occlusion Device in Left Atrial Appendage Occlusion - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Left Atrial Appendage Occlusion

Intervention / Treatment

Device: Medtronic LAA Occlusion Device

Study Type

Interventional

Enrollment (Actual)

40

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Rancho Mirage, California, United States, 92270
    - Eisenhower Medical Center
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale University School of Medicine
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Oklahoma Heart Hospital
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete occlusion of the left atrial appendage Time Frame: 3 Months	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the composite incidence rate of device-related adverse events Time Frame: Discharge/30 days	Discharge/30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

Study Chair: Patrick McCarthy, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria