AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery (EXCLUDE)
This study has been completed.
Sponsor:
AtriCure, Inc.
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00779857
First received: October 23, 2008
Last updated: May 31, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Left Atrial Appendage Exclusion |
Device: AtriCure LAA Exclusion System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by AtriCure, Inc.:
Primary Outcome Measures:
- Rate of Device Related Serious Adverse Events [ Time Frame: Discharge/30 days Post Procedure ] [ Designated as safety issue: Yes ]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.
- Percent of Patients With Complete Occlusion of the Left Atrial Appendage. [ Time Frame: 3 Months Post Procedure ] [ Designated as safety issue: No ]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.
| Enrollment: | 70 |
| Study Start Date: | September 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AtriCure LAA Exclusion System
AtriCure LAA Exclusion System
|
Device: AtriCure LAA Exclusion System
Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779857
Locations
| United States, Georgia | |
| Macon Medical Center | |
| Macon, Georgia, United States, 31201 | |
| United States, Indiana | |
| St. Francis Heart Hospital | |
| Indianapolis, Indiana, United States, 45237 | |
| United States, Michigan | |
| Spectrum Health | |
| Grand Rapids, Michigan, United States, 49506 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Mount Carmel East Hospital | |
| Columbus, Ohio, United States, 43213 | |
| United States, Texas | |
| Baylor Heart Hospital | |
| Plano, Texas, United States, 75093 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
AtriCure, Inc.
Investigators
| Principal Investigator: | Michael Mack, MD | Baylor Heart Hospital |
More Information
No publications provided by AtriCure, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AtriCure, Inc. |
| ClinicalTrials.gov Identifier: | NCT00779857 History of Changes |
| Other Study ID Numbers: | CP2008-2 |
| Study First Received: | October 23, 2008 |
| Results First Received: | February 11, 2013 |
| Last Updated: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AtriCure, Inc.:
|
left atrial appendage laa atrial fibrillation afib |
af stroke tia |
ClinicalTrials.gov processed this record on June 18, 2013