Safety and Effectiveness of Left Atrial Appendage Occlusion

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: AtriCure LAA Exclusion System

• Registration Number: NCT00567515
• Lead Sponsor: AtriCure, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Primary Completion: 2010-07
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAA Clip	AtriCure LAA Exclusion System	AtriCure LAA Exclusion System

Primary Outcome Measures

Name	Time	Method
Safety - Device related complications	30 days
Efficacy - Occlusion of the LAA	6 months

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland