Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography

NCT06472102 | Recruiting

• 1 other identifier: 17/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Syncope, Vasovagal

Keywords

cardioneuroablation; syncope

Outcome Measures

Primary Outcomes (1)

• Predictive value of fragmented atrial potentials

  Sensitivity, specificity, positive and negative predictive value of fragmented atrial potentials for the acute efficacy of cardioneuroablation

  During procedure (2 hours)

Secondary Outcomes (5)

• Localization of presumed areas of ganglionated plexi

  During procedure (2 hours)

• Accuracy of identification of sites where effective cardioneuroablation was performed

  During procedure (2 hours)

• Number of deflections of fragmented atrial potentials at inferior and superior areas of ganglionated plexi

  During procedure (2 hours)

• Duration of fragmented atrial potentials at inferior and superior areas of ganglionated plexi

  During procedure (2 hours)

• Amplitude of fragmented atrial potentials at inferior and superior areas of ganglionated plexi

  During procedure (2 hours)

Interventions

Cardioneuroablation PROCEDURE

Endocardial radio-frequency ablation of areas of ganglionated plexi in the left and the right atrium

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• severe, recurrent symptoms due to reflex syncope with ECG documented asystole \>3 seconds, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia
• history of ineffective prior non-pharmacological treatment and positive baseline atropine test (sinus rate acceleration \> 30% and no AV block following 2 mg of intravenous atropine) -
• informed written consent obtained

You may not qualify if:

• contraindications to perform cardioneuroablation
• contraindications to perform computed tomography with intravenous contrast injection
• lack of informed written consent obtained

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Masovian Voivodeship, 04-073, Poland

RECRUITING

Related Publications (5)

• Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.

  PMID: 15670960 BACKGROUND

• Lellouche N, Buch E, Celigoj A, Siegerman C, Cesario D, De Diego C, Mahajan A, Boyle NG, Wiener I, Garfinkel A, Shivkumar K. Functional characterization of atrial electrograms in sinus rhythm delineates sites of parasympathetic innervation in patients with paroxysmal atrial fibrillation. J Am Coll Cardiol. 2007 Oct 2;50(14):1324-31. doi: 10.1016/j.jacc.2007.03.069. Epub 2007 Sep 17.

  PMID: 17903630 BACKGROUND

• Aksu T, De Potter T, John L, Osorio J, Singh D, Alyesh D, Baysal E, Kumar K, Mikaeili J, Dal Forno A, Yalin K, Akdemir B, Woods CE, Salcedo J, Eftekharzadeh M, Akgun T, Sundaram S, Aras D, Tzou WS, Gopinathannair R, Winterfield J, Gupta D, Davila A. Procedural and short-term results of electroanatomic-mapping-guided ganglionated plexus ablation by first-time operators: A multicenter study. J Cardiovasc Electrophysiol. 2022 Jan;33(1):117-122. doi: 10.1111/jce.15278. Epub 2021 Oct 25.

  PMID: 34674347 BACKGROUND

• Kulakowski P, Baran J, Sikorska A, Krynski T, Niedzwiedz M, Soszynska M, Piotrowski R. Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance. Heart Rhythm. 2024 Mar;21(3):282-291. doi: 10.1016/j.hrthm.2023.11.022. Epub 2023 Nov 29.

  PMID: 38036236 BACKGROUND

• Francia P, Viveros D, Falasconi G, Soto-Iglesias D, Fernandez-Armenta J, Penela D, Berruezo A. Computed tomography-based identification of ganglionated plexi to guide cardioneuroablation for vasovagal syncope. Europace. 2023 Jun 2;25(6):euad170. doi: 10.1093/europace/euad170.

  PMID: 37343139 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Piotrowski, MD PhD

  Department of Cardiology, Grochowski Hospital, Medical Centre for Postgraduate Education

  STUDY DIRECTOR

Central Study Contacts

Piotr Kułakowski, MD PhD

CONTACT

+48 22 5152757; kulak@kkcmkp.pl

Agnieszka Sikorska, MD PhD

CONTACT

+48 22 5152757; sikorska.agnieszka.anna@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 24, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From December 2025 to December 2027
• Access Criteria: e-mail contacts

Locations

PL (1)