Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation

AtriCure, Inc.53 sites in 1 country600 target enrollmentSeptember 2015

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: AtriCure, Inc.
Enrollment: 600
Locations: 53
Primary Endpoint: Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

This study will be conducted in two stages:

Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)
Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

March 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AtriCure, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
•Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter ablation;
•Life expectancy ≥ 1 year;
•Willing and able to return to and comply with scheduled follow-up visits and tests; and
•Willing and able to provide written informed consent

Exclusion Criteria

•Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
•Any prior epicardial ablation or any type of left-sided atrial ablation procedure;
•LA diameter \> 6 cm as measured by computerized tomography and confirmed by the imaging core laboratory;
•Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned study intervention;
•Currently exhibits New York Heart Association Class IV heart failure symptoms;
•Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
•Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
•Documented history of unstable angina within 3 months prior to the planned study intervention;
•Documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated within 3 months prior to the planned study intervention;
•Documented symptomatic carotid disease, defined as \> 70% stenosis or \> 50% stenosis with symptoms;

Outcomes

Primary Outcomes

Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation

Time Frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure

Measured by 24-hour Holter Monitoring

Secondary Outcomes

Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD(Following the 90 day blanking period through 12 months post-index pulmonary vein isolation)
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee(12 months following index pulmonary vein isolation)