Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

Study Overview
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Brief Summary
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In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month. A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.

Official Title
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Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function

Conditions
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Atrial Fibrillation, Heart Failure, Systolic

Intervention / Treatment
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* Procedure: Cryoballoon ablation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required), LVEF <40% on sinus rhythm, symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment, age >21 years old. Exclusion criteria: previous left atrial ablation, left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view), strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy, pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing, known primary electrical heart disease (e.g. Brugada syndrome), presence of thrombus in a heart chamber, presence of prosthetic valve at any position, moderate/severe valvular heart disease, active infectious disease or malignancy, moderate or severe hepatic impairment (Child-Pugh class B or C), severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2), inability or unwillingness to adhere to standard treatment or to provide consent.

Ages Eligible for Study
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Minimum Age: 21 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoballoon ablation<br>A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. | Procedure: Cryoballoon ablation<br>* Left atrial ablation using cryoballoon to achieve pulmonary vein isolation<br>|
| No Intervention: Standard treatment<br>Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to exceed AG burden cut-off of 1% | The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time) | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality or hospitalization for heart failure | Time to the composite of all-cause mortality and unplanned hospitalization for heart failure | Up to 2 years |