Study:
A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.
Rationale:
n/a
Purpose:
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical
investigation conducted at 26 investigational sites in the United States and Canada.
Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after
efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide,
propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental
Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12
months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation
by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring,
patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12
months. The first 90 days after study therapy was initiated was considered a blanked period
for all subjects.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Paroxysmal Atrial Fibrillation |
Device: Arctic Front® Cryoablation Catheter
Drug: Flecainide or Sotalol or Propafenone |
Phase 3 |
Verified by
Medtronic Atrial Fibrillation Solutions
July, 2012
Sponsored by: Medtronic Atrial Fibrillation Solutions
Information provided by: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov identifier: NCT00523978
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Douglas L. Packer, MD., Principal Investigator