Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

Study Overview
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Brief Summary
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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%).

Official Title
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Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

Conditions
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Atrial Fibrillation, Heart Failure, Cryoballon Ablation

Intervention / Treatment
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* Procedure: Cryoballoon Pulmonary Vein Isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Heart Failure<br>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. | Procedure: Cryoballoon Pulmonary Vein Isolation<br>* 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.<br>|
| Other: Normal cardiac function<br>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. | Procedure: Cryoballoon Pulmonary Vein Isolation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures (number of deaths) | Number of all-cause death | 60 months | 
| Secondary Outcome Measures (procedural success) | 2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins | 60 months | 
| Secondary Outcome Measures (rehospitalization) | 3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes | 60 months | 
| Secondary Outcome Measures (procedure duration) | 4. Total procedure duration and left-atrial dwell time (in minutes) | 60 months | 
| Secondary Outcome Measures (total time) | 5. Total fluoroscopy time (in minutes) | 60 months | 
| Secondary Outcome Measures (total contrast use) | 6. Total contrast dye use (in milliliters) | 60 months |