Safety and Effectiveness of Left Atrial Appendage Occlusion
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
AtriCure LAA Exclusion System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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:
- intra-venous catecholamines
- ventilator
- 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
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAA Clip
Arm Description
AtriCure LAA Exclusion System
Outcomes
Primary Outcome Measures
Safety - Device related complications
Efficacy - Occlusion of the LAA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567515
Brief Title
Safety and Effectiveness of Left Atrial Appendage Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAA Clip
Arm Type
Experimental
Arm Description
AtriCure LAA Exclusion System
Intervention Type
Device
Intervention Name(s)
AtriCure LAA Exclusion System
Intervention Description
Placement of clip of LAA.
Primary Outcome Measure Information:
Title
Safety - Device related complications
Time Frame
30 days
Title
Efficacy - Occlusion of the LAA
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
intra-venous catecholamines
ventilator
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Genoni, MD, Professor
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29016813
Citation
Caliskan E, Sahin A, Yilmaz M, Seifert B, Hinzpeter R, Alkadhi H, Cox JL, Holubec T, Reser D, Falk V, Grunenfelder J, Genoni M, Maisano F, Salzberg SP, Emmert MY. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. 2018 Jul 1;20(7):e105-e114. doi: 10.1093/europace/eux211.
Results Reference
derived
PubMed Identifier
23657550
Citation
Emmert MY, Puippe G, Baumuller S, Alkadhi H, Landmesser U, Plass A, Bettex D, Scherman J, Grunenfelder J, Genoni M, Falk V, Salzberg SP. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial. Eur J Cardiothorac Surg. 2014 Jan;45(1):126-31. doi: 10.1093/ejcts/ezt204. Epub 2013 May 8.
Results Reference
derived
PubMed Identifier
19880144
Citation
Salzberg SP, Plass A, Emmert MY, Desbiolles L, Alkadhi H, Grunenfelder J, Genoni M. Left atrial appendage clip occlusion: early clinical results. J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. doi: 10.1016/j.jtcvs.2009.06.033. Epub 2009 Nov 1.
Results Reference
derived
Learn more about this trial
Safety and Effectiveness of Left Atrial Appendage Occlusion
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