Left Atrial Appendage Exclusion Study

Atrial Appendage Clinical Trial

— PLACE II  

Official title:

Left Atrial Appendage Exclusion Study II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983605
• Other study ID #: RS-001 V3.0_120709
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2016
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Appendage

Intervention

Device:
• LARIAT Suture Delivery Device
LAA exclusion procedure

Locations

Country	Name	City	State
Poland	Jagiellonian University (John Paul II) Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of device related serious adverse events		30 days
Primary	Percent of patients with complete exclusion of the LAA measured with TEE		90 days