N/A N=81 Treatment

Continued Access Protocol

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00889681 ↗

Enrolled (actual)

Serious AEs

15.4%

Results posted

Apr 2014

Primary outcome: Primary: Cryoablation Procedure Events (CPEs) — 1; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Arctic Front Cardiac Cryoablation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Cryoablation Procedure Events (CPEs)	1; 0; 0; 0; 1; 0	—
PRIMARY Acute Procedural Success (APS)	75	—
PRIMARY Freedom From Major Atrial Fibrillation Events (MAFE)	74; 4; 0; 2; 0; 0	—
PRIMARY Long-term Clinical Success	51	—

Summary

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

Eligibility Criteria

Inclusion Criteria

Subjects must fulfill ALL of the following criteria:

Documented PAF:
diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), 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
18 and 75 years of age
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 of the following is regarded as a criterion for excluding a subject from the study:

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%
2º (Type II) or 3º 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
Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
negative β-HCG test within 7 days prior to Start Date
history of surgical sterilization
postmenopausal and free of menses for at least 12 months.
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00889681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.