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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Appendage
• Intervention / Treatment: Device: LARIAT RS Suture Delivery Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Jagiellonian University (John Paul II) Hospilal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAA exclusion procedure; LAA exclusion with the LARIAT RS Suture Delivery Device	Device: LARIAT RS Suture Delivery Device; LARIAT RS Suture Delivery Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RS-003 V1.0_30Oct2012