Atrial Fibrillation, Left Atrial Dilatation
Conditions
Keywords
Atrial fibrillation, Left atrial dilatation, Pulmonary vein isolation, AV node ablation, Conduction System pacing, Quality of Life, Age group 70 to 85 years
Brief summary
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.
Interventions
PROCEDUREConduction System pacing and AV node ablation
See study arm description.
PROCEDUREAtrial fibrillation ablation by pulmonary vein isolation
See study arm description
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomized to either 1. Conduction system pacing via His-pacing electrode, in combination with AV node ablation 2. Pulmonary vein isolation ablation
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines * LVEF \>35% * Age 70-85 years * Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2) * Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist) * Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent
Exclusion criteria
* Chronic atrial fibrillation with \>1 year duration * BMI \>40kg/m2 * Hypertrophic cardiomyopathy * Severe heart failure with symptoms ≥ NYHA class IIIb * Heart amyloidosis * Cardiac sarcoidosis * Recent (\<3 months) myocardial infarction * Significant heart valve disease (pronounced insufficiency or stenosis) * Pacemaker or ICD treatment ongoing, or current pacemaker indication * Congenital heart disease that required surgical correction * Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related Quality of Life: questionnaire | 12 months | Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental Quality of Life: questionnaire | 12 months | Improvement of the mental health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire |
| Arrhythmia related Quality of Life: ASTA questionnaire | 12 months | 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 |
| Anxiety and depression | 12 months | 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 |
| Ejection fraction | 12 months | Change in left ventricular systolic ejection fraction |
| Biomarker for heart failure | 12 months | Change in NT-ProBNP level |
| Safety endpoint: Proportion of patients with major adverse events | 12 months | 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). |
| Electrocardiography changes | 12 months | Change in QRS duration on ECG |
| Health economy | 12 months | Total atrial fibrillation and device related health care cost |
| Survival | 3 years | Total survival and survival free of major complications |
| Hospitalization for heart failure | 3 years | 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 |
| Physical performance | 12 months | Change in six minute walk test distance |
Countries
Sweden
Outcome results
None listed