Expired Study
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Indianapolis, Indiana 45237


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.


Criteria:

Inclusion Criteria: 1. Subject is greater than or equal to 18 years of age. 2. 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) 3. 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. 4. Subject is willing and able to provide written informed consent. 5. Subject has a life expectancy of at least 1 year. 6. Subject is willing and able to return for scheduled follow-up visits. Exclusion Criteria: 1. Previous cardiac surgery 2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip. 3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair. 4. NYHA Class IV heart failure symptoms 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) 6. Creatinine >200 µmol/L 7. LAA is not appropriate for exclusion based on intraoperative evaluations 8. Current diagnosis of active systemic infection 9. Renal failure requiring dialysis or hepatic failure 10. A known drug and/or alcohol addiction 11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study 12. Pregnancy or desire to get pregnant within 12-months of the study treatment 13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes 14. Patients who have been treated with thoracic radiation 15. Patients in current chemotherapy 16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases. 17. Patients with known connective tissue disorders


Study is Available At:


Original ID:

CP2008-2


NCT ID:

NCT00779857


Secondary ID:


Study Acronym:

EXCLUDE


Brief Title:

AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AtriCure, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Mack, MD
Principal Investigator
Baylor Heart Hospital

Study Dates

Start Date:September 2008
Completion Date:October 2011
Completion Type:Actual
Primary Completion Date:October 2009
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 31, 2013
First Received Date:October 23, 2008
First Results Date:February 11, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
Time Frame:3 Months Post Procedure
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Rate of Device Related Serious Adverse Events
Time Frame:Discharge/30 days Post Procedure
Safety Issues:True
Description: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 lite

Study Interventions

Intervention Type:Device
Name:AtriCure LAA Exclusion System
Description:Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
Arm Name:AtriCure LAA Exclusion System

Study Arms

Study Arm Type:Experimental
Arm Name:AtriCure LAA Exclusion System
Description:AtriCure LAA Exclusion System

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AtriCure, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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