NCT04512586Terminated
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Reason given: Recruitment too slow. Unrealistic to finish study with full inclusion cohort.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 1 Jul 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 26 Feb 2025
- Lead sponsor
- Region Skane
- Diseases
- Atrial fibrillation
- NCT number
- NCT04512586
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Congenital heart disease that required surgical correction
Other
- Chronic atrial fibrillation with >1 year duration
- BMI >40kg/m2
- Hypertrophic cardiomyopathy
- Pacemaker or ICD treatment ongoing, or current pacemaker indication
- Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival
Who the study is looking for
- 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
Age in the registry: 70 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linköping University | Linköping | Sweden | Unknown status |
| Skåne University Hospital | Lund | Sweden | Unknown status |
| Stockholm Arrhythmia Center | Stockholm | Sweden | Unknown status |
| Varberg Hospital | Varberg | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.