Atrial Fibrillation, Severe Heart Failure
Conditions
Keywords
cryoablation, conventional treatment of heart failure
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.
Interventions
PROCEDURECryoablation
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.
Sponsors
Military Institute od Medicine National Research Institute
Clinical Hospital No. 2 Pomeranian Medical University, Szczecin, Poland
Hospital name Pope John Paul, Zamosc, Poland
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 required intravenous diuretic or pressor administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who had ischaemic cerebral stroke during 12 months follow up | one year | ischaemic cerebral stroke confirmed in computed tomography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | one year | The Minnesota Living with Heart Failure Questionnaire |
| Left ventricle ejection fraction assessment | one year | transthoracic echocardiography |
| Patient capacity assessment | six months | six minute walk test |
| Oxygen consumption assessment | six months | cardio-pulmonary exercise test |
| Percentage of patients requiring hospitalization because of arrhythmias' incidence or symptoms (atrial fibrillation/ atrial flutter) | one year | patients who required pharmacological or electrical cardioversion |
| Percentage of biventricular pacing assessment | one year | the percentage of biventricular pacing assessed on the device interrogation |
| Percentage of patients with arrhythmias incidence | one year | the effectiveness of the cryoablation assessed on the device interrogation; atrial fibrillation burden at least 30 seconds |
Countries
Poland
Contacts
Primary ContactZbigniew Kalarus, MD, Ph.D.
Outcome results
None listed