"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
Age: 14Years +
All Genders
ID06472102
Value of Fragmented Atrial Electrograms, Computed Tomography, and Intracardiac Echocardiography for Identifying Optimal Sites for Radio-frequency Delivery During Cardioneuroablation for Asystolic Reflex Syncope
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 cardioneuroablation (CNA) as a new treatment method for asystolic reflex syncope, a condition involving severe fainting episodes related to heart rate pauses. This study focuses on comparing three techniques—intracardiac recordings of fragmented atrial electrograms (FAP), intracardiac echocardiography (ICE), and computed tomography (CT)—to identify the best sites for targeting ganglionated plexi (GP), nerve clusters in the heart fat tissue that CNA aims to treat. The goal is to improve the accuracy and effectiveness of CNA by understanding how these methods overlap and predict successful nerve ablation. The study involves 100 patients undergoing CNA at a single institution. The procedure uses a 3.5 mm irrigated tip catheter with electroanatomical mapping and ICE guidance under general anesthesia. Ablation targets GP areas identified primarily by ICE and electroanatomical mapping, while the operator remains blinded to FAP and CT results. The extracardiac vagal stimulation (ECVS) technique is used during the procedure to confirm successful vagal nerve denervation, which is the treatment goal. CT scans are performed beforehand and merged with mapping data afterward to compare anatomical findings. Fragmented atrial electrograms are recorded and analyzed to assess their predictive value for effective ablation. Participants will undergo detailed heart mapping, electrogram recording, CT imaging, and several tests including atropine response and ECVS during the procedure lasting around 2 hours. Researchers will analyze the characteristics of fragmented atrial potentials, their anatomical correlations with ICE and CT findings, and their role in predicting effective CNA sites. Safety and procedural outcomes will be closely monitored, and all patients provide informed consent before participation. The primary outcome is the predictive value of fragmented atrial potentials during the procedure, with secondary outcomes including accuracy and localization of GP areas.
CONDITIONS
Brief Title
Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography
Who Can Participate
Age: 14Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Severe, recurrent reflex syncope symptoms with ECG showing asystole longer than 3 seconds, especially if injury occurred, or recurrent presyncope with persistent reflex bradycardia
- History of ineffective prior non-pharmacological treatment
- Positive baseline atropine test with sinus rate increase over 30% and no AV block after 2 mg intravenous atropine
- Provided informed written consent to participate
You will not qualify if you...
- Contraindications to performing cardioneuroablation
- Contraindications to undergoing computed tomography with intravenous contrast
- Lack of informed written consent
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 - Approximately 2 hours
Participants undergo cardioneuroablation, an endocardial radio-frequency ablation procedure targeting areas of ganglionated plexi in the left and right atrium under general anesthesia, guided by intracardiac echocardiography and electro-anatomical mapping.
1 in-person procedural visit
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland, 04-073
Actively Recruiting
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Research Team
P
Piotr Kułakowski, MD PhD
A
Agnieszka Sikorska, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Functional characterization of atrial electrograms in sinus rhythm delineates sites of parasympathetic innervation in patients with paroxysmal atrial fibrillation.
Nicolas Lellouche, Eric Buch, Andrew Celigoj...
https://pubmed.ncbi.nlm.nih.gov/17903630Procedural and short-term results of electroanatomic-mapping-guided ganglionated plexus ablation by first-time operators: A multicenter study.
Tolga Aksu, Tom De Potter, Leah John...
https://pubmed.ncbi.nlm.nih.gov/34674347Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance.
Piotr Kulakowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/38036236Computed tomography-based identification of ganglionated plexi to guide cardioneuroablation for vasovagal syncope.
Pietro Francia, Daniel Viveros, Giulio Falasconi...
https://pubmed.ncbi.nlm.nih.gov/37343139