Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tambocor, Sotalol, Propafenone
Flecainide or Sotalol or Propafenone · 1 trial · 1 indication
Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.
Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.
Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.
Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Experimental subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci. If necessary, experimental subjects were allowed a previously failed Study Atrial Fibrillation Drug (AF Drug). |
| Control | ACTIVE_COMPARATOR | Control Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed. |
| Name | Type | Description |
|---|---|---|
| Arctic Front® Cryoablation Catheter | DEVICE | Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system. |
| Flecainide or Sotalol or Propafenone | DRUG | Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day |
Inclusion Criteria: * Documented Paroxysmal Atrial Fibrillation (PAF): PAF diagnosis, 2 episodes of PAF within the last 2 months, at least 1 episode of PAF must be documented * Age 18-75 * Documented Effectiveness Failure of one (1) AF drug * Willing to be randomized to either group and do full 12 ...