PULSED AF
Research type
Research Study
Full title
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)
IRAS ID
294758
Contact name
Lucas Peternelli
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 19 days
Research summary
Cardiac Ablation therapy is used to treat irregular heart rhythms, including the most common one, atrial fibrillation (AF). Cardiac ablation therapy is established as an acceptable therapy to treat patients with AF when drug therapy has failed. Current ablation systems ablate heart tissue by either heating or freezing the tissue. These systems can cause problems that are significant and potentially life threatening to the patient, such as causing air bubbles in the heart, that can move and cause stroke, damage to parts of the heart ( such as the outermost layer of the heart ( the pericardium), damage to other organs ( such as the oesophagus), and damage to blood vessels which can result in them becoming blocked.
This therapy( Pulsed Field Ablation (PFA) system) is novel with regards to how the energy that is delivered to the heart is controlled, which in theory will reduce the amount of energy needed to ablate the target tissue, and potentially reduce the problems seen when the current systems are used. The study aims to establish how safe and how well this therapy works.
The study looks at patients who have AF that either lasts less than seven days (paroxysmal AF) or longer than 7 days (persistent AF). This procedure is done in a cardiac catheter laboratory, where a thin tube with wires (catheter), is inserted from a blood vessel in the groin, and positioned in a specific position in the heart. Once it is in the correct position, electrical energy is delivered through the catheter to the heart. The amount of energy delivered is controlled by the doctor through a dedicated device called a generator. The goal is that the electrical energy terminates or stops (ablates) the abnormal pathways that allow AF to occur.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0089
Date of REC Opinion
25 May 2021
REC opinion
Further Information Favourable Opinion