Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium. Patient population: 90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation. Primary endpoint: Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation. Secondary endpoints: Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
See study arm description.
See study arm description
Linköping University
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Stockholm Arrhythmia Center
Stockholm, Sweden
Varberg Hospital
Varberg, Sweden
Health related Quality of Life: questionnaire
Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire
Time frame: 12 months
Safety endpoint: Proportion of patients with major adverse events
Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury).
Time frame: 12 months
Mental Quality of Life: questionnaire
Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire
Time frame: 12 months
Arrhythmia related Quality of Life: ASTA questionnaire
Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia. and Arrhythmia (ASTA) questionnaire
Time frame: 12 months
Anxiety and depression
Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety
Time frame: 12 months
Ejection fraction
Change in left ventricular systolic ejection fraction
Time frame: 12 months
Biomarker for heart failure
Change in NT-ProBNP level
Time frame: 12 months
Physical performance
Change in six minute walk test distance
Time frame: 12 months
Electrocardiography changes
Change in QRS duration on ECG
Time frame: 12 months
Health economy
Total atrial fibrillation and device related health care cost
Time frame: 12 months
Survival
Total survival and survival free of major complications
Time frame: 3 years
Hospitalization for heart failure
Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years
Time frame: 3 years
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