AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

NCT00779857 | Completed Phase 2 Results DMC

• 1 other identifier: CP2008-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Left Atrial Appendage Exclusion

Keywords

left atrial appendage; laa; atrial fibrillation; afib; af; stroke; tia

Outcome Measures

Primary Outcomes (2)

• Rate of Device Related Serious Adverse Events

  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.

  Discharge/30 days Post Procedure

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

  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.

  3 Months Post Procedure

Study Arms (1)

AtriCure LAA Exclusion System

EXPERIMENTAL

AtriCure LAA Exclusion System

Device: AtriCure LAA Exclusion System

Interventions

AtriCure LAA Exclusion System DEVICE

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

AtriCure LAA Exclusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (7)

Macon Medical Center

Macon, Georgia, 31201, United States

Location

St. Francis Heart Hospital

Indianapolis, Indiana, 45237, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49506, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mount Carmel East Hospital

Columbus, Ohio, 43213, United States

Location

Baylor Heart Hospital

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJ Jr, Salamon T, Mack MJ. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1. doi: 10.1016/j.jtcvs.2011.07.052. Epub 2011 Sep 8.

  PMID: 21906756 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia

Results Point of Contact

• Title: Jim Lucky
• Organization: AtriCure, Inc.

jlucky@atricure.com

1-513-755-4101

Study Officials

• Michael Mack, MD

  Baylor Heart Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2011
• Last Updated: June 4, 2013
• Results First Posted: June 4, 2013

Record last verified: 2013-05

Locations

US (7)