Left Atrial Appendage Exclusion Study (PLACE II)

AtriCure

Status: Completed

Conditions: Atrial Appendage

Treatments: Device: LARIAT Suture Delivery Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01983605

RS-001 V3.0_120709

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Treatment

Experimental group

Description:

LAA exclusion with the LARIAT Suture Delivery Device

Treatment:

Device: LARIAT Suture Delivery Device