The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,420
Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Germany
Primary Outcome Measures (Number of recurrence)
Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure
Time frame: 60 months
Primary Outcome Measures (number of safety events)
2\. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)
Time frame: 60 months
Secondary Outcome Measures (number of deaths)
Number of all-cause death
Time frame: 60 months
Secondary Outcome Measures (procedural success)
2\. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins
Time frame: 60 months
Secondary Outcome Measures (rehospitalization)
3\. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes
Time frame: 60 months
Secondary Outcome Measures (procedure duration)
4\. Total procedure duration and left-atrial dwell time (in minutes)
Time frame: 60 months
Secondary Outcome Measures (total time)
5\. Total fluoroscopy time (in minutes)
Time frame: 60 months
Secondary Outcome Measures (total contrast use)
6\. Total contrast dye use (in milliliters)
Time frame: 60 months
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