Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.

Launched by 4TH MILITARY CLINICAL HOSPITAL WITH POLYCLINIC, POLAND · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for patients who have a pacemaker due to a condition called bradycardia, which means their heart beats too slowly. The trial compares a newer method called cardioneuroablation (CNA) with traditional pacemaker therapy. CNA aims to help patients with bradycardia caused by excessive nerve activity and may even allow some patients to stop using their pacemakers altogether. The goal is to see if CNA can effectively improve symptoms and reduce reliance on pacemakers, while also ensuring it is safe for patients.

To participate in this trial, patients need to be between 18 and 65 years old and have received a pacemaker before the age of 50 due to specific heart issues. Participants will be randomly assigned to one of three groups: one group will receive the new CNA treatment, another will continue with traditional pacemaker therapy, and the last group will be observed without any immediate treatment. Throughout the study, which lasts about 18 months, participants will undergo various assessments to monitor their heart health and symptoms. This trial is crucial as it could lead to better options for managing bradycardia in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction
• • Positive response to atropine test
• • Age between 18-65 years
• • Signed informed consent to participate in the study
• Exclusion Criteria:
• • Own heart rate \<30/min
• • Fainting after pacemaker therapy initiation
• • Persistent and sustained atrial fibrillation
• • History of myocarditis
• • History of myocardial infarction
• • History of cardiac surgery
• • History of ablation procedures
• • Congenital heart defects
• • Congenital atrioventricular block
• • Neuromuscular and neurodegenerative diseases
• • Indications for expanding the pacemaker system to ICD/CRT-D
• • Pregnancy
• • Renal insufficiency with GFR \<30 ml/min/1.73m2
• • Age below 18 and above 65 years
• • HAS-BLED score \>/= 3 points