A study comparing atrioventricular junction ablation (AVJA) versus continued optimum medical rate control in patients with cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) with suboptimal heart rate control on optimum medication.
Patients fulfilling the enrolment criteria will be randomly (randomization with variable blocks of 4, 6, and 8 patients) allocated to intervention and control groups in a 1:1 ratio. AVJA will be done in patients belonging to the intervention group without undue delay after the randomization. The procedure will be repeated in case of recovery of AV nodal conduction during the trial. CRT device will be programmed to a base rate of 70 bpm, hysteresis switched off, and rate response functions activated unless not tolerated by the patient. The triggered mode will be encouraged. All patients will be regularly followed in outpatient clinics. Cross-over to the AVJA study arm will be considered and performed at any time during the trial at the discretion of the operators. This may particularly concern patients with clinical deterioration in terms of functional status, quality of life, systolic left ventricular function, and/or repeated hospitalization, and in whom biventricular pacing (BiVP%) \<\<100% could be suspected as a significant underlying factor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Ablation of the atrioventricular (AV) node is a procedure used to disrupt or break the electrical connection between the upper heart chambers (the atria) and the lower heart chambers (the ventricles).
Optimal medication therapy according to the prescription of the physician.
Regional Hospital Liberec
Liberec, Liberec Region, Czechia
RECRUITINGUniversity Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
RECRUITINGHeart failure (HF) events
The number of HF events will be observed.
Time frame: 3 years
36-Item Quality of Life (QoL)
QoL will be assessed using the 36-Item Quality of Life Questionnaire. QoL will be evaluated at 12, 24 and 36 months as a sum of points that are assigned to individual outcome measures, specifically to their change compared to the baseline. To score the SF-36, scales are standardized to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Time frame: 3 years
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
MLHFQ values will be recorded and evaluated at 12, 24 and 36 months. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
Time frame: 3 years
Dose of loop diuretics
Change in the dose of loop diuretics will be observed and recorded. This parameter will be evaluated at 12, 24 and 36 months as an increase or decrease of the dose compared to the baseline.
Time frame: 3 years
NYHA classification
Changes in the New York Heart Association classification (NYHA) will be observed. The NYHA classification values will be evaluated at 12, 24 and 36 months. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.
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Hospital Podlesí, Inc.
Třinec, Moravian-Silesian Region, Czechia
University Hospital Olomouc
Olomouc, Olomouc Region, Czechia
RECRUITINGHospital České Budějovice
České Budějovice, South Bohemian Region, Czechia
RECRUITINGSt. Anne's University Hospital Brno
Brno, South Moravian, Czechia
RECRUITINGUniversity Hospital Brno
Brno, South Moravian, Czechia
RECRUITINGInstitute of Clinical and Experimental Medicine
Prague, Czechia
RECRUITINGMilitary University Hospital Prague
Prague, Czechia
RECRUITINGTime frame: 3 years
All-cause death
Patient deaths from all causes will be observed, recorded and analysed.
Time frame: 3 years
Death from cardiovascular diseases (CV death)
Incidents of CV death will be observed, recorded and analysed.
Time frame: 3 years
Combined heart failure (HF) death and HF hospitalization
Incidents of combined heart failure (HF) death and HF hospitalization will be observed, recorded and analysed.
Time frame: 3 years
Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)
The time-averaged proportional change in NT-pro-BNP will be observed, recorded and analysed.
Time frame: 3 years
Days in the hospital because of heart failure (HF)
The number of days in the hospital because of heart failure (HF) will be recorded.
Time frame: 3 years
Time-averaged change in the NYHA class
The time-averaged change in the NYHA class will be observed, recorded and analysed.
Time frame: 3 years