Biosense Webster, part of Johnson & Johnson Medical Devices Companies, has treated the first patients in Europe with VARIPULSE catheter for atrial fibrillation (AF) in the inspIRE clinical trial.
VARIPULSE Catheter is a steerable, multi-electrode catheter that helps in cardiac mapping and pulsed-field ablation (PFA), using the investigational Trupulse Generator.
Statistics show that AF, the most common type of cardiac arrhythmia, affects 33 million people worldwide. By 2030, the number is expected to increase by up to 70%.
The multi-centre, non-randomised trial will enrol more than 300 patients who will be treated with the investigational VARIPULSE Catheter.
It will analyse the safety and effectiveness of the VARIPULSE Catheter and Trupulse Generator in patients with symptomatic drug-refractory recurrent paroxysmal (intermittent) AF.
The primary objective is to analyse the number of participants with primary adverse events (PAEs) within one week post-procedure and rate of disease freedom.
The trial’s secondary objectives will be to analyse the number of participants achieving acute procedural success and rate of disease freedom from day 90 to 365.
The total score of change from baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) will also be analysed.
Diverse techniques, catheter designs and energy sources were studied to advance the treatment of AF.
PFA is a novel approach to treating AF by using a controlled electric field instead of thermal energy to ablate and scar cardiac tissue through a process called irreversible electroporation (IRE).
The ablation method may spare other tissues from inadvertent ablation, including the oesophagus, pulmonary vein connective tissue and the phrenic nerve.
Biosense Webster worldwide president Uri Yaron said: “The inspIRE study is an important step toward a potentially significant advancement in treatment options for atrial fibrillation patients.
“We eagerly await data from the study as more investigators have access to this novel technology aimed at advancing the treatment of cardiac arrhythmias.”
Last week, Biosense secured the US Food and Drug Administration (FDA) approval for its HERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent AF.