LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS

Atrial Appendage Clinical Trial

Official title:

LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059707
• Other study ID #: RS-003 V1.0_30Oct2012
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2017
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.

Description:

Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age = 21 years

2. Diagnosed non-valvular atrial fibrillation

3. Current CHADS2 score = 2

4. Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)

5. Life expectancy of = 1 year

6. Willing and able to provide written informed consent

7. Willing and able to come to and comply with scheduled follow-up visits

Exclusion Criteria:

1. Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)

2. Prosthetic heart valve or ring in any position

3. Current NYHA Class IV heart failure symptoms

4. Current right heart failure

5. Myocardial infarction or unstable angina within last 3 months

6. Current cardiogenic shock or hemodynamic instability

7. Current symptomatic carotid disease

8. Need for an intra-aortic balloon pump or intravenous inotropes

9. Embolic stroke or transient ischemic attack (TIA) within the last 30 days.

10. Current diagnosis of active systemic infection

11. Need for emergent cardiac surgery (e.g., cardiogenic shock)

12. Current renal failure requiring dialysis

13. Current clinical evidence of cirrhosis

14. Any history of thoracic radiation

15. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases

16. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)

17. Any history of pericarditis

18. Pectus excavatum (clinically defined by treating physician)

19. Severe scoliosis

20. Pregnancy or desire to get pregnant within the next 12 months.

21. LVEF < 30%

22. Current participation in a clinical investigation that involves an active treatment arm.

23. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study

24. Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)

Related Conditions & MeSH terms

• Atrial Appendage

Intervention

Device:
• LARIAT RS Suture Delivery Device
LARIAT RS Suture Delivery Device

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with complete exclusion	To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month.	90 days
Secondary	Secondary Exploratory objectives of procedural success and device-related complication rates	The rate of procedural success; The rate of complications related to the use of the LARIAT RS and accessories	3 month