Left Atrial Appendage Exclusion Study

Not Applicable

Completed

• Conditions: Atrial Appendage

• Registration Number: NCT01983605
• Lead Sponsor: AtriCure, Inc.

Brief Summary

Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.

Detailed Description

The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-03
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Study Completion: 2013-12
• Status Verified: 2016-10
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Subject is greater than or equal to 18 years of age
2. Subject has atrial fibrillation (paroxysmal or persistent)
3. Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
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 left atrial appendage or left atrium
3. NYHA Class IV heart failure symptoms
4. Need for emergent cardiac surgery (i.e. cardiogenic shock)
5. LAA is not appropriate for exclusion based upon intraoperative evaluations
6. Current diagnosis of active systemic infection
7. Renal failure requiring dialysis or hepatic failure
8. A known drug and/or alcohol addiction
9. Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study
10. Pregnancy or desire to get pregnant within 12 months of the study treatment
11. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
12. Patients who have been treated with thoracic radiation
13. Patients in current chemotherapy
14. Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
15. Patients with known connective tissue disorders, i.e. Lupus
16. Previous history of pericarditis
17. Presence of a PFO/ASD or valve implant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of device related serious adverse events	30 days
Percent of patients with complete exclusion of the LAA measured with TEE	90 days

Trial Locations

Locations (1)

Jagiellonian University (John Paul II) Hospital; 🇵🇱 Krakow, Poland