Clinical Trial Details

Overview

Research Study Summary

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Purpose

To provide clinical data regarding the long-term safety and effectiveness of the Arctic Front® Cardiac Cryoablation Catheter System, including the Freezor® MAX Cardiac cryoablation catheter according to the Product Labeling.

Demonstrate effectiveness (through 36 months) by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs.

To Learn more

CW ID: 198901
Date Last Changed: August 8, 2014

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Facility Type
Out-Patient

Eligibility

Inclusion Criteria:

  • Documented PAF
  • Diagnosis of paroxysmal atrial fibrillation (PAF), and 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
  • Age 18 years or older
  • Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone,sotalol or dofetilide.

Exclusion Criteria:

  • Any previous left atrial (LA) ablation (except permissible retreatment subjects)
  • Any previous LA surgery
  • Current intracardiac thrombus (can be treated after thrombus is resolved)
  • Presence of any pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Pre-existing hemidiaphragmatic paralysis
  • Anteroposterior LA diameter > 5.5 cm by TTE
  • Presence of any cardiac valve prosthesis
  • Clinically significant mitral valve regurgitation or stenosis
  • Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
  • Unstable angina
  • Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
  • Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
  • NYHA class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) < 40%
  • 2 (Type II) or 3 atrioventricular block
  • Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
  • Brugada syndrome
  • Long QT syndrome
  • Arrhythmogenic right ventricular dysplasia
  • Sarcoidosis
  • Hypertrophic cardiomyopathy
  • Known cryoglobulinemia
  • Uncontrolled hyperthyroidism
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
  • Any woman known to be pregnant
  • Life expectancy less than one (1) year
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
  • Unwilling or unable to comply fully with study procedures and follow-up

More Info

IRB Number: 012-161

Facility Name:
The Heart Hospital Baylor Plano (THHBP)

Lead Principal Investigator:
J. B. DeVille
Email: JamesDev@baylorhealth.edu
972-964-0363

Contact

Richard Vargas, Study Coordinator
Baylor Scott & White Research Institute
3310 Live Oak Street
Dallas, TX 75204
Phone: 469-814-4473

View Map

Research Center Information:

Baylor Scott & White Research Institute

Volunteer for this Trial

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