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

Autor: Dulai R; Cardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK.; Institute of Cardiovascular Science, University College of London, London, UK., Furniss SS, Sulke N; CVS Healthcare Ltd., Eastbourne, UK., Freemantle N; Institute for Clinical Trials and Methodology, University College London, London, UK., Lambiase PD; Institute of Cardiovascular Science, University College of London, London, UK., Farwell D; Mid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK., Srinivasan NT; Mid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK., Tan S; Mid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK., Patel N; Cardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK., Graham A; Nottingham University Hospital NHS Trust, Nottingham, UK., Veasey RA; Cardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK.; Institute of Cardiovascular Science, University College of London, London, UK.
Jazyk: angličtina
Zdroj: Clinical cardiology [Clin Cardiol] 2023 Aug; Vol. 46 (8), pp. 973-980. Date of Electronic Publication: 2023 Jun 13.
DOI: 10.1002/clc.24066
Abstrakt: 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.
(© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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