Sole-Therapy Treatment of Atrial Fibrillation

Status unconfirmed · Phase 2

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT00566176

Run by

AtriCure, Inc.

People needed

25

Starts

2005-10-01

Expected to finish

2017-02-01

Last updated by the study team

2013-02-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Weight < 325 lbs

You may not qualify if…

• 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
• Presence of thrombus in the left atrium
• Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
• Patient is enrolled in another investigational study

Where it is running

• University Community Hospital/Dr. Kiran C. Patel Research Institute — Tampa, Florida, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Oklahoma Cardiac Arrythmia Research Institute — Oklahoma City, Oklahoma, United States
• Sacred Heart Medical Center Endovascular Research — Eugene, Oregon, United States
• Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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