Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

AtriCure, Inc.5 sites in 1 country25 target enrollmentOctober 2005

ConditionsAtrial Fibrillation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: AtriCure, Inc.
Enrollment: 25
Locations: 5
Primary Endpoint: The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

February 2017

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AtriCure, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient between 18 and 80 years of age
•Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
•Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
•Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
•Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
•Left Atrial Size \< 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
•Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
•Patient is willing and able to provide written informed consent.
•Patient has a life expectancy of at least 2 years.
•Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria

•Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
•Prior cardiac surgery
•Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
•Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
•Cerebrovascular accident within previous 6 months
•Known carotid artery stenosis greater than 80%
•Evidence of significant active infection
•Patient unable to undergo TEE
•Pregnant woman
•Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia

Outcomes

Primary Outcomes

The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.

Time Frame: Perioperatively

The primary safety endpoint will be determined by assessing the rate of serious adverse events.

Time Frame: Discharge/30 Days