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Completed

NCT Number: NCT00779857

AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.

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Key information

Conditions

Left Atrial Appendage Exclusion Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Attack, Transient Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Macon Medical Center, Macon, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is greater than or equal to 18 years of age.
  • Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:
  • CHADS score > 2
  • Age > 75 years
  • Hypertension and age > 65 years
  • Previous stroke
  • History of atrial fibrillation (any classification)
  • Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
  • Subject is willing and able to provide written informed consent.
  • Subject has a life expectancy of at least 1 year.
  • Subject is willing and able to return for scheduled follow-up visits.

Exclusion criteria

  • Previous cardiac surgery
  • Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
  • Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
  • NYHA Class IV heart failure symptoms
  • Need for emergent cardiac surgery (i.e. cardiogenic shock)
  • Creatinine >200 µmol/L
  • LAA is not appropriate for exclusion based on intraoperative evaluations
  • Current diagnosis of active systemic infection
  • Renal failure requiring dialysis or hepatic failure
  • A known drug and/or alcohol addiction
  • Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
  • Pregnancy or desire to get pregnant within 12-months of the study treatment
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Patients who have been treated with thoracic radiation
  • Patients in current chemotherapy
  • Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
  • Patients with known connective tissue disorders

Treatment and study plan

AtriCure LAA Exclusion System

Device

Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System

Primary outcomes

  1. Rate of Device Related Serious Adverse Events

    Time frame: Discharge/30 days Post Procedure

    The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.

  2. Percent of Patients With Complete Occlusion of the Left Atrial Appendage.

    Time frame: 3 Months Post Procedure

    The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery

Acronym: EXCLUDE

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Oct 24, 2008
Registry last updated
Jun 4, 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.

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