His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation (NCT04512586) | Clinical Trial Compass
TerminatedNot Applicable
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Stopped: Recruitment too slow. Unrealistic to finish study with full inclusion cohort.
Sweden45 participantsStarted 2020-09-01
Plain-language 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.
Who can participate
Age range
70 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.