Arrhythmias & electrophysiology
Pulmonary vein isolation versus SHAM-pulmonary vein isolation for symptomatic relief in patients with atrial fibrillation—Design and rationale of the PVI-SHAM-AF trial
Study context
- Population
- Patients with atrial fibrillation (AF) eligible for pulmonary vein isolation (PVI)260 planned
- Planned comparison
- PVI vs sham procedure
- Primary endpoint
- Change in quality of life (standardized questionnaire) from baseline
- Follow-up
- 6 months
Methodological detailsdesign and rationale, multicentre, prospective, sham-controlled, double-blinded, 2:1 randomisation, Follow-up at 3, 6 and 12 months: AF symptoms, quality of life (AFEQT, SF-36, EQ-5D), AF burden, NT-proBNP
- Design and rationale
- Multicentre
- Prospective
- Sham-controlled
- Double-blinded
- 2:1 randomisation
- Follow-up at 3, 6 and 12 months: AF symptoms, quality of life (AFEQT, SF-36, EQ-5D), AF burden, NT-proBNP
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Pulmonary vein isolation versus SHAM-pulmonary vein isolation for symptomatic relief in patients with atrial fibrillation—Design and rationale of the PVI-SHAM-AF trial. Am Heart J. Published 11 June 2025. doi:10.
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