PRECEPT

STUDY IDENTIFIER:

PRECEPT

CONDITION:

Persistent Atrial Fibrillation; Arrhythmias

CONTACT INFO:

Tammy Haas   |   tammy.haas@allina.com   |   612-863-6226

DESCRIPTION:

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.
   

INVESTIGATORS:

Daniel Melby, MD

SPONSORS:

Biosense Webster, Inc.

STATUS:

Open/Enrolling