The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)

Last updated: November 26, 2024
Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Kidney Disease

Circulation Disorders

Treatment

Rocuronium

Propofol

Clinical Study ID

NCT06707532
4_2024
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with requirement for PFA ablation for cardiac indications and ability toprovide informed consent for study participation

Exclusion

Exclusion Criteria:

  • Patients with allergies to the general anaesthetics used, genetic diseases of theneuromuscular plateau - e.g. Duchenne dystrophy, myasthenia gravis - and patientswho do not gived informed consent to participate in the study will be excluded fromthe study.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Rocuronium
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 01, 2025

Study 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].

Connect with a study center

  • 4th Military Clinical Hospital with Polyclinic

    Wrocław, Dolnośląskie 50-981
    Poland

    Active - Recruiting

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