Clinical trial NCT03062241: Ablation of Atrial Fibrillation in Heart Failure Patients
Official title: Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Severe Heart Failure
Keywords: cryoablation
conventional treatment of heart failure
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Military Institute od Medicine National Research Institute
name: Clinical Hospital No. 2 Pomeranian Medical University, Szczecin, Poland
name: Hospital name Pope John Paul, Zamosc, Poland
First posted: 2017-02-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
timeFrame: one year
measure: Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
timeFrame: one year
measure: Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
timeFrame: one year
measure: Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
timeFrame: one year
Secondary outcomes:
measure: Percentage of patients who had ischaemic cerebral stroke during 12 months follow up
timeFrame: one year
Other outcomes:
measure: Percentage of patients with arrhythmias incidence
timeFrame: one year
measure: Percentage of patients with arrhythmias incidence
timeFrame: one year
measure: Quality of life assessment
timeFrame: one year
measure: Left ventricle ejection fraction assessment
timeFrame: one year
measure: Patient capacity assessment
timeFrame: six months
measure: Oxygen consumption assessment
timeFrame: six months
measure: Percentage of patients requiring hospitalization because of arrhythmias' incidence or symptoms (atrial fibrillation/ atrial flutter)
timeFrame: one year
measure: Percentage of biventricular pacing assessment
timeFrame: one year
Locations:
city: Zabrze
country: Poland
facility: Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
Study officials:
affiliation: Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
name: Zbigniew Kalarus, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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