Ablation of Atrial Fibrillation in Heart Failure Patients

Study Overview
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Brief Summary
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The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations, mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..

Detailed Description
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Atrial fibrillation (AF) is one of the most common arrhythmia worldwide and the risk of AF incidence increases with age. The amount of patients suffered from AF is still underestimated due to insufficient diagnosing silent AF. The incidence of patients with silent, asymptomatic AF might be approx. 80% , particularly in patients with heart failure. The most frequent consequence of undiagnosed AF is not only thromboembolism but also heart failure development and loss of quality of life. The incidence of chronic heart failure (CHF), which is the most frequent consequence of coronary heart disease, still increases and nowadays in patients above 70 years affects approx.10%. What is more, AF which is one of the result of CHF occurred in 30% of those patients. Atrial fibrillation ablation is one of the most established method to treat symptomatic patients and its' efficacy is about 70 - 90 %. Hence, the appropriate and effective treatment of those patients might influence not only on the survival but also the quality of life and functionality of health care system. Among many data about AF in patients with impaired LV (left ventricle) systolic function there is still a lack of randomized, multicenter trials which would compare the influence of AF cryoablation with conventional treatment in patients with LVEF (left ventricle ejection fraction) ≤ 35% (despite optimal pharmacotherapy) on long term survival and efficacy. The deficiency in this field was an inspiration to conduct this study.

Official Title
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Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure

Conditions
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Atrial Fibrillation, Severe Heart Failure

Intervention / Treatment
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* Procedure: Cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years ≤ age ≤ 75 years optimal pharmacotherapy within the last 3 months New York Heart Association (NYHA) II- IV (out-patient) within the last 3 months AF paroxysmal, persistent or persistant long-lasting at least 1 episode of paroxysmal AF with the duration of ≥ 30 s or AF burden ≥ 10% during 1 month up to 1 year since ICD or CRT-D implantation signed informed consent Exclusion Criteria: age < 18 years or > 75 years permanent AF contraindications to oral anticoagulation or heparin prior AF ablation chronic kidney disease requiring dialysis untreated hypo- or hyperthyroidism breast feeding pregnancy decompensated heart failure within the last 90 days requiring pressor infusion stroke within the last 3 months myocardial infarction within the last 3 months PCI or CABG within the last 3 months active myocarditis artificial valve replacement surgery severe mitral or aortic stenosis coronary artery disease requiring revascularization heart transplant participation in another study comorbidities with expected survival less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: This is a Randomized Controlled Trial (RCT), non-blinded, prospective, multicentre performed in up to 4 cardiology centers in Poland. All patients implanted with a dual-chamber implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) with Home Monitoring capabilities and history of paroxysmal, persistent or persistant long-lasting AF will be screened for the study. In patient who fulfill all inclusion and none of the exclusion criteria 1 year after ICD or CRT-D implantation, with exclusion of 1 month directly after implantation, a device check-up and AF burden will be performer and assessed. Randomization will be performed using sealed envelopes and will be conducted in the coordinating center of the study PI in all patients who sign informed consent and met all inclusions and none of the exclusion criteria. The cryoablation of AF will be performed within 1 month from randomization in the invasive treatment group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation<br>The pulmonary vein (PV) isolation in patients randomized to intervention group. | Procedure: Cryoablation<br>* After left atrial appendage (LAA) thrombus exclusion, the transseptal puncture will be performed and intravenous heparin will be administered to achieve Activated Clotting Time (ACT) ≥300 seconds.The pulmonary vein (PV) isolation will be performed. Optimal cryoballoon positioning will be confirmed by PVs angiography. Pulmonary veins isolation will be confirmed by entrance/exit block using appropriate catheter. During cryoablation of the right PVs, high-output right phrenic nerve stimulation will be performed using a diagnostic catheter placed in the superior vena cava. Whenever decrease/loss of pacing capture will be observed, cryoablation will be immediately terminated.<br>|
| No Intervention: Conventional treatment<br>Pharmacological treatment according to 2016 ESC (European Society of Cardiology) guidelines for the diagnosis and treatment of acute and chronic heart failure and to 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with European Association for Cardio-Thoracic Surgery (EACTS). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant. | percentage of patients who required intravenous diuretic or pressor administration | one year | 
| Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant. | percentage of patients who died | one year | 
| Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant. | percentage of patients who required mechanical left ventricle support | one year | 
| Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant. | percentage of patients who had a heart transplant | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who had ischaemic cerebral stroke during 12 months follow up | ischaemic cerebral stroke confirmed in computed tomography | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryoablation, conventional treatment of heart failure