N/A
N=402
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Paroxysmal Atrial Fibrillation (PAF)
Bottom Line
View on ClinicalTrials.gov: NCT01456949 ↗Enrolled (actual)
402
Serious AEs
40.4%
Results posted
Jan 2019
Primary outcome: Primary: Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months — 66.9 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic Arctic Front® Cardiac CryoAblation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months |
66.9 | <0.001 sig |
| PRIMARY Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months |
2.3 | <0.001 sig |
| SECONDARY Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years. |
90.3; 83.2; 77.8 | — |
| SECONDARY Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years |
80.4; 72.8 | — |
Summary
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
Eligibility Criteria
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, AND
- At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
- Age 18 years or older
- Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
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%
- 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
- 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 not pre-approved by Medtronic
- Unwilling or unable to comply fully with study procedures and followup
Data sourced from ClinicalTrials.gov (NCT01456949). 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.