LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS
1 other identifier
interventional
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 6, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJanuary 9, 2020
March 1, 2017
11 months
February 6, 2014
January 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Secondary Exploratory objectives of procedural success and device-related complication rates
3 month
Study Arms (1)
LAA exclusion procedure
EXPERIMENTALLAA exclusion with the LARIAT RS Suture Delivery Device
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 21 years
- Diagnosed non-valvular atrial fibrillation
- Current CHADS2 score ≥ 2
- Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
- Life expectancy of ≥ 1 year
- Willing and able to provide written informed consent
- Willing and able to come to and comply with scheduled follow-up visits
You may not qualify if:
- Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
- Prosthetic heart valve or ring in any position
- Current NYHA Class IV heart failure symptoms
- Current right heart failure
- Myocardial infarction or unstable angina within last 3 months
- Current cardiogenic shock or hemodynamic instability
- Current symptomatic carotid disease
- Need for an intra-aortic balloon pump or intravenous inotropes
- Embolic stroke or transient ischemic attack (TIA) within the last 30 days.
- Current diagnosis of active systemic infection
- Need for emergent cardiac surgery (e.g., cardiogenic shock)
- Current renal failure requiring dialysis
- Current clinical evidence of cirrhosis
- Any history of thoracic radiation
- Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (1)
Jagiellonian University (John Paul II) Hospilal
Krakow, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2014
First Posted
February 11, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
January 9, 2020
Record last verified: 2017-03