Safety and Effectiveness of Left Atrial Appendage Occlusion

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567515
• Other study ID #: OUS 2007-1
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2007
• Last updated: February 12, 2013
• Start date: September 2007
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AtriCure LAA Exclusion System
Placement of clip of LAA.

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Device related complications		30 days	Yes
Primary	Efficacy - Occlusion of the LAA		6 months	No