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

BACKGROUND: Catheter ablation by pulmonary vein isolation (PVI) has a class IA recommendation for patients with atrial fibrillation (AF) resistant or intolerant to antiarrhythmic drug therapy to reduce symptoms, recurrence and progression of AF. However, the symptomatic effect of catheter ablation is difficult to quantitate in the absence of a double-blind trial with a sham procedure control. The PVI-SHAM-AF trial aims to compare the effects of catheter ablation versus a sham procedure on patient-reported outcomes using standardized AF questionnaires. STUDY DESIGN: The PVI-SHAM-AF trial is a multicentre, prospective, randomized, sham-controlled, double-blinded clinical trial. The trial plans to enrol 260 patients. Patients eligible for PVI are randomly assigned in a 2:1 ratio to receive either PVI or a sham procedure. The Sham procedure involves introducing a venous sheath under deep analgosedation, maintained for at least 60 minutes; electrical cardioversion is performed if atrial fibrillation is present. Follow-up assessments are planned at 3-, 6-, and 12-months postbaseline, focusing on AF symptoms, quality of life assessments assessed by the AFEQT, SF-36, EQ-5D questionnaires, and clinical outcomes such as AF burden and NT-proBNP levels. The primary objective is the change in quality of life (measured by a standardized questionnaire) from baseline to 6 months of follow-up, compared to the sham procedure. CONCLUSION: The PVI-SHAM AF trial will assess the true (sham-controlled) effect of catheter ablation for AF on quality of life.