Atrial Fibrillation, Cryoballon Ablation, Heart Failure
Conditions
Brief summary
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%).
Interventions
PROCEDURECryoballoon Pulmonary Vein Isolation
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.
Sponsors
St. Josefs-Hospital Wiesbaden GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic paroxysmal or persistent atrial fibrillation * Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group) * Patients with normal cardiac function (assigned to control group) * Age \> 18 years * Consent capacity
Exclusion criteria
* Age under 18 years * Pregnancy * Lack of consent capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measures (Number of recurrence) | 60 months | 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 |
| Primary Outcome Measures (number of safety events) | 60 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures (procedural success) | 60 months | 2\. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins |
| Secondary Outcome Measures (rehospitalization) | 60 months | 3\. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes |
| Secondary Outcome Measures (total time) | 60 months | 5\. Total fluoroscopy time (in minutes) |
| Secondary Outcome Measures (total contrast use) | 60 months | 6\. Total contrast dye use (in milliliters) |
| Secondary Outcome Measures (procedure duration) | 60 months | 4\. Total procedure duration and left-atrial dwell time (in minutes) |
| Secondary Outcome Measures (number of deaths) | 60 months | Number of all-cause death |
Countries
Germany
Outcome results
None listed