PLANET-AF
Research type
Research Study
Full title
Pulsed Field Ablation during Left Atrial Appendage Occlusion: A Randomised Controlled Trial
IRAS ID
327077
Contact name
Dhiraj Gupta
Contact email
Sponsor organisation
Liverpool Heart & Chest Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk.
In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming.
There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting.
Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. Hence we propose a randomised controlled trial of LAAO+PFA vs LAAO alone in those referred for LAAO. Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0053
Date of REC Opinion
20 Mar 2024
REC opinion
Further Information Favourable Opinion