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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
AtriCure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
December 3, 2007
Last Updated
February 12, 2013
Sponsor
AtriCure, Inc.
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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

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Safety and Effectiveness of Left Atrial Appendage Occlusion

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