Persistent Atrial Fibrillation; Arrhythmias
The purpose of this study is to demonstrate the safety and effectiveness of the investigational THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and RF ablation procedures.
CRITERIA LIST/ QUALIFICATIONS:
- Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year and is documented by the following:
- Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
- Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
- 24-hour Holter within 90 days of the ablation procedure showing continuous AF.
- Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
Daniel Melby, MD
Biosense Webster, Inc.