Skip to main content
OpenTrials
Completed

NCT Number: NCT00567515

Safety and Effectiveness of Left Atrial Appendage Occlusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AtriCure LAA Exclusion System

Device

Placement of clip of LAA.

Primary outcomes

  1. Safety - Device related complications

    Time frame: 30 days

  2. Efficacy - Occlusion of the LAA

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Dec 5, 2007
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.