Actively Recruiting
Observational Study of Cardioneuroablation and Pacemaker Treatment for Adults Under 60 With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias
Led by Rush University Medical Center · Updated on 2025-09-18
300
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to observe and collect data on patients with symptomatic vasovagal syncope and bradyarrhythmias who are managed through routine medical care. It includes patients under 60 years old who have received care for symptoms that did not improve with behavioral or medical treatments. The study compares those receiving medical therapy alone with those undergoing radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation. Patients are divided into two groups for analysis a control group consisting of patients awaiting intervention and managed medically, and a procedural group including patients who have undergone successful cardioneuroablation or pacemaker implantation. Those who cross over from awaiting intervention to receiving the procedure are followed from the time of their intervention. Patients receiving pacemakers during the study are removed from the control group after the procedure. Participants will be monitored over several years to track episodes of syncope, time to first recurrence, and symptom burden. Additional assessments include heart rate changes after ablation, procedure-related complications, quality of life before and after treatment, and the occurrence of atrial arrhythmias. The study offers long-term follow-up to evaluate outcomes up to three years, with regular evaluations conducted throughout the study period.
CONDITIONS
Brief Title
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Research Team
A
Alexander Mazur, MD
J
Jeanne du Fay de Lavallaz, MD
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