Left Atrial Appendage Exclusion Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atrial Appendage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

LAA exclusion with the LARIAT Suture Delivery Device

Group Type EXPERIMENTAL

LARIAT Suture Delivery Device

Intervention Type DEVICE

LAA exclusion procedure

Interventions

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LARIAT Suture Delivery Device

LAA exclusion procedure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No