Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,420
- Locations
- 2
- Primary Endpoint
- Primary Outcome Measures (Number of recurrence)
Study Overview
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%).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Primary Outcome Measures (Number of recurrence)
Time Frame: 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)
Time Frame: 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)
Primary Outcome Measures (Number of recurrence)
Time Frame: 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)
Time Frame: 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 Outcomes
- Secondary Outcome Measures (number of deaths)(60 months)
- Secondary Outcome Measures (procedural success)(60 months)
- Secondary Outcome Measures (rehospitalization)(60 months)
- Secondary Outcome Measures (procedure duration)(60 months)
- Secondary Outcome Measures (total time)(60 months)
- Secondary Outcome Measures (total contrast use)(60 months)
- Secondary Outcome Measures (number of deaths)(60 months)
- Secondary Outcome Measures (procedural success)(60 months)
- Secondary Outcome Measures (rehospitalization)(60 months)
- Secondary Outcome Measures (procedure duration)(60 months)
- Secondary Outcome Measures (total time)(60 months)
- Secondary Outcome Measures (total contrast use)(60 months)