"Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation.
Jose C Pachon, Enrique I Pachon, Juan C Pachon...
https://pubmed.ncbi.nlm.nih.gov/15670960Actively Recruiting
Age: 18Years - 60Years
All Genders
ID06166277
Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
Led by Rush University Medical Center · Updated on 2025-09-18
300
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Symptomatic vasovagal syncope or symptomatic bradyarrhythmia that has not improved with behavioral and medical treatments
- Age less than 60 years
You will not qualify if you...
- Age greater than 60 years
- Intra- or infra-Hisian AV block
- Intrinsic sinus node disease
- History of supraventricular tachycardia
- History of ventricular tachycardia
- Presence of structural heart disease
- Prior history of catheter ablation
- Presence of inheritable arrhythmic conditions
- Orthostatic hypotension on head-up tilt test
- Abnormal thyroid function levels
- Proven indication for permanent pacemaker implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 3 years
Participants who are awaiting intervention or managed with medical therapy are observed under routine care.
Regular follow-up visits as part of routine care
Implementation
Duration - Single day procedure with immediate post-procedure care
Participants undergo cardioneuroablation procedure or permanent pacemaker placement as part of their routine care.
1 day procedure visit
Long-term Monitoring
Duration - Up to 3 years
After the procedure, participants are followed for outcomes including syncope recurrence, heart rate changes, and quality of life.
Follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Rush University Medical Centert
Chicago, Illinois, United States, 60657
Actively Recruiting
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Research Team
A
Alexander Mazur, MD
J
Jeanne du Fay de Lavallaz, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results.
Jose Carlos M Pachon, Enrique Indalecio M Pachon, Maria Zelia Cunha Pachon...
https://pubmed.ncbi.nlm.nih.gov/21712276Ganglionated Plexi Ablation to Treat Patients with Refractory Neurally Mediated Syncope and Severe Vagal-Induced Bradycardia.
Mauricio Scanavacca, Denise Hachul
https://pubmed.ncbi.nlm.nih.gov/31314822Cardioneuroablation for Treatment of Atrioventricular Block.
Tolga Aksu, Rakesh Gopinathannair, Serdar Bozyel...
https://pubmed.ncbi.nlm.nih.gov/34465122Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial.
Roman Piotrowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/36114133