Safety and Effectiveness of Left Atrial Appendage Occlusion - Full Text View

Sponsored by:	AtriCure, Inc.
Information provided by:	AtriCure, Inc.
ClinicalTrials.gov Identifier:	NCT00567515

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Device: AtriCure LAA Occlusion System	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study: Surgical Left Atrial Appendage (LAA) Exclusion With the LAA Occlusion Clip for Patients With Atrial Fibrillation Undergoing a Maze Procedure

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:

Safety - Device related complications [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Efficacy - Occlusion of the LAA [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Occlusion of the left atrial appendage using the AtriCure LAA Occlusion System

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567515

Contacts

Contact: Madonna Katenkamp	1-800-401-3506	mkatenkamp@atricure.com
Contact: Jim Lucky	1-800-401-3506	jlucky@atricure.com

Locations

Switzerland
University Hospital of Zurich	Recruiting
Zurich, Switzerland
Contact: Sacha Salzberg sacha.salzberg@gmail.com
Principal Investigator: Michele Genoni, MD, Professor
Sub-Investigator: Sacha Salzberg

Sponsors and Collaborators

AtriCure, Inc.

Investigators

Principal Investigator:

Michele Genoni, MD, Professor

University of Zurich

More Information

Responsible Party:	AtriCure, Inc. ( Jim Lucky )
Study ID Numbers:	OUS 2007-1
Study First Received:	December 3, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00567515
Health Authority:	Switzerland: Swissmedic

Keywords provided by AtriCure, Inc.:

Atrial Fibrillation
AF
afib
Stroke
TIA
Thromboembolism

Cerebrovascular Accident
Clip
Watchman
Occlusion
Exclusion
CABG

Study placed in the following topic categories:

Heart Diseases
Cerebral Infarction
Stroke

Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009