Cardioneuroablation and Ventricular Proarrhythmia

NCT06458140 | Recruiting

• 1 other identifier: 16/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.

Conditions

Syncope, Vasovagal

Keywords

cardioneuroablation; reflex syncope; ventricular arrhythmia

Outcome Measures

Primary Outcomes (1)

• Inducibility of ventricular arrhythmias

  Programmed ventricular stimulation is used to assess vulnerability to ventricular arrhythmia at baseline and after cardioneuroablation

  2 hours

Secondary Outcomes (4)

• Corrected QT interval

  2 hours

• QT interval dispersion

  2 hours

• Right ventricular action potential duration

  2 hours

• Effective refractory period of the right ventricle

  2 hours

Interventions

Cardioneuroablation PROCEDURE

Radiofrequency ablation of ganglionated plexi of the heart

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
• history of ineffective prior non-pharmacological treatment
• positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine)
• informed written consent to participate in the study

You may not qualify if:

• Lack of consent to participate in the study
• Contraindications to perform right ventricular stimulation

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, 04-073, Poland

RECRUITING

Related Publications (6)

• Chakraborty P, Chen PS, Gollob MH, Olshansky B, Po SS. Potential consequences of cardioneuroablation for vasovagal syncope: A call for appropriately designed, sham-controlled clinical trials. Heart Rhythm. 2024 Apr;21(4):464-470. doi: 10.1016/j.hrthm.2023.12.004. Epub 2023 Dec 16.

  PMID: 38104955 BACKGROUND

• Zhu C, Hanna P, Rajendran PS, Shivkumar K. Neuromodulation for Ventricular Tachycardia and Atrial Fibrillation: A Clinical Scenario-Based Review. JACC Clin Electrophysiol. 2019 Aug;5(8):881-896. doi: 10.1016/j.jacep.2019.06.009. Epub 2019 Aug 19.

  PMID: 31439288 RESULT

• Brack KE, Coote JH, Ng GA. Vagus nerve stimulation protects against ventricular fibrillation independent of muscarinic receptor activation. Cardiovasc Res. 2011 Aug 1;91(3):437-46. doi: 10.1093/cvr/cvr105. Epub 2011 May 16.

  PMID: 21576131 RESULT

• 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 RESULT

• Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.

  PMID: 36114133 RESULT

• 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 RESULT

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

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

Study Officials

• Roman Piotrowski, MD PhD

  Medical Centre for Postgraduate Education

  STUDY CHAIR

Central Study Contacts

Piotr Kulakowski, 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 9, 2024
• First Posted: June 13, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available from January 2025 to January 2027
• Access Criteria: direct e-mail contact

Locations

PL (1)