CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 81
- Locations
- 10
- Primary Endpoint
- Cryoablation Procedure Events (CPEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed Description
1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). 2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). 3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
Investigators
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
Outcomes
Primary Outcomes
Cryoablation Procedure Events (CPEs)
Time Frame: 365 days
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Freedom From Major Atrial Fibrillation Events (MAFE)
Time Frame: 365 days
Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Long-term Clinical Success
Time Frame: 180 days
Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which 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.
Acute Procedural Success (APS)
Time Frame: At the conclusion of the cryoablation procedure
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.