"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
Phase Not Applicable
All Genders
Healthy Volunteers
ID06440291
Effects of Cardioneuroablation on Exercise Performance in Patients With Reflex Asystolic Syncope: The Roman 3 Study
Led by Centre of Postgraduate Medical Education · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of cardioneuroablation (CNA) on exercise capacity in patients with reflex syncope caused by vagally-induced sinus arrest or atrio-ventricular block. This treatment aims to reduce symptoms by ablating parts of the parasympathetic nervous system in the heart. The study also compares exercise capacity between these patients and healthy volunteers to understand how CNA influences fitness over one year. The study involves patients undergoing CNA following a standard procedure guided by advanced imaging and electrical mapping tools under general anesthesia. CNA targets specific heart nerve clusters to achieve vagal denervation, confirmed by testing nerve activity during the procedure. Patients will have a symptom-limited cardiopulmonary exercise test (CPET) before CNA and one year after to measure exercise capacity and heart function. A control group of healthy volunteers will also complete CPET for comparison. Participants will be assessed through CPET measurements including peak oxygen uptake, heart rate response, and ventilatory efficiency. Quality of life will be measured with a dedicated questionnaire. Clinical monitoring includes heart rate, blood pressure, and electrocardiogram during exercise. The main outcome is peak oxygen uptake at 12 months, with additional heart rate and exercise duration measures. The study includes statistical analysis to compare changes and correlations between exercise performance and quality of life over the year.
CONDITIONS
Brief Title
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Severe, recurrent symptoms due to reflex syncope or recurrent presyncope caused by slow heart rate
- ECG documented asystole lasting longer than 3 seconds
- Ineffective prior non-pharmacological treatments
- Positive baseline atropine test with sinus rate increase over 30% and no atrio-ventricular block after 2 mg intravenous atropine
- Signed written informed consent to participate in the study
You will not qualify if you...
- Serious health conditions preventing general anesthesia or cardioneuroablation
- Non-functional sinus arrest or atrio-ventricular block shown by a negative atropine test
- Lack of consent to participate in the study
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.
screening and enrollment visit
Treatment
Duration - 1 day
Participants undergo the cardioneuroablation procedure under general anesthesia to treat reflex syncope by ablating specific cardiac nerve areas.
1 procedure visit (in-person)
Follow-up
Duration - 12 months
Participants are monitored over one year to assess exercise capacity and heart function through cardiopulmonary exercise testing.
2 visits (baseline and 12 months post-procedure) for cardiopulmonary exercise testing
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
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Research Team
P
Piotr Kulakowski, PhD
A
Anieszka Sikorska, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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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/21712276Cardioneuroablation 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/36114133Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance.
Piotr Kulakowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/38036236Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association.
Gary J Balady, Ross Arena, Kathy Sietsema...
https://pubmed.ncbi.nlm.nih.gov/20585013The development and preliminary validation of a scale measuring the impact of syncope on quality of life.
Marianne Sarah Rose, Mary-Lou Koshman, Debbie Ritchie...
https://pubmed.ncbi.nlm.nih.gov/19797151