Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT06707532
Brief Summary:
The study aims to improve the safety of the electroporation ablation (PFA) procedure by using muscle relaxants to reduce skeletal muscle damage during the procedure. It will also assess myocardial damage to improve the procedure's quality and speed up recovery after the procedure.
Detailed Description:
The procedure of electroporation (PFA) is a method of atrial fibrillation ablation introduced in Poland in 2022. A biphasic high voltage current (2000 volts) is applied to the electrode placement site. Local coagulation of the site is followed by myocardial scarring and interruption of the pathological conduction pathway of premature electrical impulses in the heart. The patient, once qualified by the cardiologist for the procedure of electroporation ablation (PFA), will undergo a standard anaesthetic qualification process with assessment of basic demographics, comorbid conditions, medications taken, determination on the surgical risk scale.
Participants will be randomized into 2 groups. Group I will consist of patients undergoing general anaesthesia without the muscle relaxant rocuronium. Group II will consist of patients undergoing general anaesthesia with the muscle relaxant rocuronium. A total of 32 patients were initially planned for the study (16 patients in each of the two groups). Before the procedure, the anaesthetist will be given a sealed envelope by a person unrelated to the project (hospital administration staff) with a randomised method of anaesthesia based on simple randomisation. Before the procedure, each patient will have a transthoracic ultrasound of the heart (TTE). The patient will not know which study group he/she has been assigned to. The operator performing the procedure will not be informed about the type of anaesthesia used \[double blind randomisation\].
Study:
NCT06707532
Study Brief:
Protocol Section:
NCT06707532