STOP Persistent AF
Purpose
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
Condition
- Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF - Failure or intolerance of at least one Class I or III antiarrhythmic drug - Age 18 or older (or older than 18 if required by local law)
Exclusion Criteria
- Left atrial diameter > 5.0 cm (anteroposterior) - Prior left atrial ablation or surgical procedure (including left atrial appendage closures) - Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months - Presence of any pulmonary vein stents - Presence of any pre-existing pulmonary vein stenosis - Pre-existing hemidiaphragmatic paralysis - Presence of any cardiac valve prosthesis - +3 and +4 mitral valve regurgitation or stenosis - Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date - Unstable angina - New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE)) - Primary pulmonary hypertension - Rheumatic heart disease - Thrombocytosis, thrombocytopenia - Any condition contraindicating chronic anticoagulation - Active systemic infection - Hypertrophic cardiomyopathy - Cryoglobulinemia - Uncontrolled hyperthyroidism - Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date - Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence - Life expectancy less than one year - Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic - Known allergies or hypersensitivities to adhesives - Known drug or alcohol dependency - Unwilling or unable to comply fully with study procedures and follow-up
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter |
|
More Details
- Status
- Completed
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure