Ablation of Atrial Fibrillation in Heart Failure Patients

Not Applicable

• Conditions: Atrial Fibrillation; Severe Heart Failure
• Interventions: Procedure: Cryoablation

• Registration Number: NCT03062241
• Lead Sponsor: Medical University of Silesia

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-04
• Last Update Posted: 2017-11-07
• Primary Completion: 2018-07-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	The pulmonary vein (PV) isolation in patients randomized to intervention group.

Primary Outcome Measures

Name	Time	Method
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.	one year	percentage of patients who had a heart transplant

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who had ischaemic cerebral stroke during 12 months follow up	one year	ischaemic cerebral stroke confirmed in computed tomography

Trial Locations

Locations (1)

Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases; 🇵🇱 Zabrze, Poland