Journal Article

A randomized sham‐controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM‐PVI study): Study design and rationale

Freemantle, Nick, Patel, Nikhil, Furniss, Stephen S., Dulai, Rajdip, Sulke, Neil, Veasey, Rick A., Tan, Stuart, Lambiase, Pier D., Graham, Adam, Farwell, David, Srinivasan, Neil T.

2023

Overview

Introduction Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. Hypothesis & Methods The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM‐PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. Results Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. Conclusion This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden. The SHAM‐PVI study timeline. One hundred forty patients will be enrolled and randomized in a 1:1 ratio to receive cryoablation or a sham procedure. All patients will receive an implantable loop recorder. Outcomes will be assessed at 3 and 6 months post‐randomisation with the first 3 months constituting the blanking period.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc
• Subject: Ablation / Anesthesia / Angina pectoris / atrial fibrillation / Atrial Fibrillation - diagnosis / Atrial Fibrillation - surgery / Cardiac arrhythmia / catheter ablation / Catheter Ablation - adverse effects / Catheter Ablation - methods / Catheters / Clinical Study Design / Committees / Consent / cryoablation / Cryosurgery - adverse effects / Cryosurgery - methods / Double-Blind Method / Ejection fraction / Enrollments / Heart Atria / Heart surgery / Humans / Intervention / Medical personnel / Patients / Performance evaluation / placebo / Placebo effect / pulmonary vein isolation / Pulmonary Veins - surgery / Quality of life / Randomized Controlled Trials as Topic / Recurrence / sham / Treatment Outcome