Cardioneuroablation for Reflex Syncope and Exercise Capacity

NCT06440291 | Recruiting

• 1 other identifier: 501-1-10-14-24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in \> 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people.

Conditions

Syncope, Vasovagal

Keywords

syncope

Outcome Measures

Primary Outcomes (1)

• peak Vo2

  peak Vo2 = maximum amount of oxygen that body can absorb and use during exercise (ml/kg/min)

  12 months

Secondary Outcomes (6)

• chronotropic index

  12 months

• METs

  12 months

• HR peak

  12 months

• HR reserve

  12 months

• exercise duration

  12 months

Other Outcomes (1)

• Quality of Life

  12 months

Study Arms (1)

cardioneuroablation

EXPERIMENTAL

Cardioneuroablation procedure as described in the Methods section of the study

Procedure: Cardioneuroablation

Interventions

Cardioneuroablation PROCEDURE

Cardioneuroablation procedure performed according to the protocol

cardioneuroablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• severe, recurrent symptoms due to reflex syncope or recurrent presyncope due to slow heart rate
• ECG documented asystole \>3 seconds
• ineffective prior non-pharmacological treatment
• positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine)
• signed written informed consent

You may not qualify if:

• serious comorbidities precluding general anaesthesia and cardioneuroablation
• non-functional sinus arrest or atrio-ventricular block (negative atropine test)
• lack of consent to participate in the study

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)

• 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

• Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.

  PMID: 21712276 BACKGROUND

• 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 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

• Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.

  PMID: 20585013 BACKGROUND

• Rose MS, Koshman ML, Ritchie D, Sheldon R. The development and preliminary validation of a scale measuring the impact of syncope on quality of life. Europace. 2009 Oct;11(10):1369-74. doi: 10.1093/europace/eup106.

  PMID: 19797151 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, PhD

  Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

  STUDY DIRECTOR

Central Study Contacts

Piotr Kulakowski, PhD

CONTACT

604455081; kulak@kkcmkp.pl

Anieszka Sikorska, PhD

CONTACT

604106455; 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: May 28, 2024
• First Posted: June 3, 2024
• Study Start: May 2, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 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: 24 months
• Access Criteria: personal e-mail contact

Locations

PL (1)