Status:
TERMINATED
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Lead Sponsor:
Region Skane
Conditions:
Atrial Fibrillation
Left Atrial Dilatation
Eligibility:
All Genders
70-85 years
Phase:
NA
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 abl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04512586
Start Date
September 1 2020
End Date
February 26 2025
Last Update
March 4 2025
Active Locations (4)
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1
Linköping University
Linköping, Sweden
2
Skane University Hospital
Lund, Sweden, 221 85
3
Stockholm Arrhythmia Center
Stockholm, Sweden
4
Varberg Hospital
Varberg, Sweden