Safety and Effectiveness of Left Atrial Appendage Occlusion

February 12, 2013 updated by: AtriCure, Inc.
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

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

  • Switzerland
      • Zurich, Switzerland
        • University Hospital of Zürich

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Documented history (paroxysmal, persistent or permanent) of AF [one episode within the last 12 months of enrollment]
  2. Elective Maze procedure
  3. Suitable anatomy
  4. Able and willing to sign informed consent
  5. Age over 18 years

Exclusion Criteria:

  1. Patient from Intensive Care Unit with either:

    1. intra-venous catecholamines
    2. ventilator
    3. cardiac index <1.8 l/min.
  2. Reoperative Cardiac Surgery
  3. Systemic or Inflammatory disease
  4. Dialysis
  5. Recent myocardial infarction (< 21 days)
  6. History of pericarditis
  7. Patient taking part in any other device or drug study
  8. Patient with known sensitivity or allergy to any of the device components
  9. Pregnancy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAA Clip
AtriCure LAA Exclusion System
Device: AtriCure LAA Exclusion System
Placement of clip of LAA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety - Device related complications
Time Frame: 30 days
30 days
Efficacy - Occlusion of the LAA
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

AtriCure, Inc.

Investigators

  • Principal Investigator: Michele Genoni, MD, Professor, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUS 2007-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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