PVI-SHAM-AF
Pulmonary Vein Isolation versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients with Atrial Fibrillation
Patient / Population Intervention / Exposure Comparison Outcome
In 262 patients with symptomatic atrial fibrillation, pulmonary vein isolation was compared with a sham procedure on AF-specific quality of life at 6 months.
N
262
Design
multicentre (8 sites in Germany, 1 in Poland), prospective, double-blind, sham-controlled RCT; 2:1 PVI vs sham procedure; participants, care providers, investigators and outcome assessors masked; follow-up at 3, 6 and 12 months
Endpoint
change in AFEQT score from baseline to 6 months after randomisation