Actively Recruiting
Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography
Led by Centre of Postgraduate Medical Education · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope, however, optimal methods for identification of presumed sites of ganglionated plexi (GP), which are the target for CNA and are located in the epicardial fat, have not yet been established. This study will compare the accuracy of three methods used for identification of these areas: intracardiac recordings of fractionated atrial electrograms, intracardiac echocardiography and computed tomography. The study group will consist of 100 patients undergoing CNA in our institution. The procedure will be performed in a standard manner with the use of extracardiac vagal stimulation as the intraprocedural end-point. Correlation between the three methods used for localisation of optimal sites for CNA as well as their predictive value for achieving effective CNA will be computed.
CONDITIONS
Official Title
Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe, recurrent reflex syncope with ECG showing asystole longer than 3 seconds, especially if linked to injury, or recurrent presyncope with persistent reflex bradycardia
- History of unsuccessful non-pharmacological treatment
- Positive baseline atropine test with sinus rate acceleration over 30% and no AV block after 2 mg intravenous atropine
- Signed informed consent to participate in the study
You will not qualify if you...
- Contraindications to cardioneuroablation procedure
- Contraindications to computed tomography with intravenous contrast
- Lack of signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland, 04-073
Actively Recruiting
Research Team
P
Piotr Kułakowski, MD PhD
CONTACT
A
Agnieszka Sikorska, MD PhD
CONTACT
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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