Cardioneuroablation: Comparison of Right Versus Left Atrial Approach in Patients With Reflex Syncope

NCT05225532 | Terminated

• 1 other identifier: 89/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Reflex vaso-vagal syncope (VVS) is the most frequent cause of transient loss of consciousness and it's treatment remains a challenge. Cardioneuroablation (CNA) is a relatively new and promising method, however, the optimal technique for performing CNA has not been established. Aim. To compare effectiveness of CNA performed in the right atrium (RA) versus left atrium (LA) in achieving total vagal denervation and in preventing syncope recurrences. Methods. Study group. Consecutive patients with recurrent cardioinhibitory or mixed VVS, undergoing CNA between January 2022 and February 2024 will be randomized to the RA or LA groups. CNA is performed under general anesthesia with muscle relaxation using a 3.5 mm irrigated tip contact force catheter and ablation index.The whole procedure is performed under intracardiac echocardiography (ICE) guidance. Efficacy of vagal denervation is assessed using extracardiac vagal stimulation (ECVS). Before starting RF delivery baseline electrophysiological parameters are measured. Next, baseline ECVS from the left and right jugular veins is performed. In the LA group, after gaining transseptal access under ICE guidance, an electroanatomical map of the LA is created and anatomically-based ablation of GP from the LA is performed. Firstly, septal GP are ablated and if total vagal denervation is not achieved, GP located close to left pulmonary veins are ablated. If ECVS still shows vagal response, additional RF applications are delivered in the RA. Then, final ECVS is performed and procedure is finished. In the RA group, GP located in this chamber are ablated and if ECVS shows persistent vagal response, transseptal puncture is performed and ablation in the LA is performed. Afterwards, final ECVS is performed. Duration of follow-up is two years. Patients will attend check-up visits at 3, 12 and 24 months with standard ECG, 24hr ambulatory ECG and QoL assessment. Primary endpoint is complete vagal denervation measured by ECVS (no sinus arrest and no AVB after CNA) using LA approach only versus RA approach only Secondary endpoints include final ECVS results and follow-up data - syncope/presyncope recurrences and QoL.

Conditions

Reflex Syncope

Outcome Measures

Primary Outcomes (1)

• No sinus arrest and no AVB after procedure completed in the LA only or RA only

  Assessment with the use of ECVS whether complete vagal denervation was achieved after procedure performed in the left atrium only versus right atrium only

  1 day

Secondary Outcomes (6)

• No sinus arrest and no AVB at the end of procedure

  1 day

• Efficacy of CNA - syncope recurrences

  24 months

• Efficacy of CNA - Time to first syncope recurrence

  1 day - 24 months

• Efficacy of CNA - syncope burden

  24 months

• Efficacy of CNA - presyncope burden

  24 months

Study Arms (2)

LA group

EXPERIMENTAL

Patients randomized to procedure performed in the left atrium

Other: Radiofrequency ablation

RA group

ACTIVE COMPARATOR

Patients randomized to procedure performed in the right atrium

Other: Radiofrequency ablation

Interventions

Radiofrequency ablation OTHER

Radiofrequency ablation of ganglionated plexi located in the left or right atrium

LA group; RA group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Documented spontaneous or tilt-induced syncope with at least 3 seconds of asystole due to sinus arrest or AVB, refractory to standard non-pharmacological treatment.
• \. High syncope burden (\> 1 syncope per year or \> 3 presyncopal events during preceding 12 months) or very severe syncope in the past, leading to injury.
• \. Significantly decreased quality of life due to syncope (\>20 points in QoL questionnaire dedicated to patients with syncope \[17\]).
• \. Standard ECG and 24hr ambulatory ECG recorded within one month before procedure.
• \. Positive baseline atropine test defined as at least 30% increase in sinus rate compared with baseline value.
• \. Obtained written informed consent.
• \. Age \> 16 years

You may not qualify if:

• \. Other possible and treatable causes of syncope such as orthostatic hypotension, IST, POTS, significant cardiac disease, cardiac arrhythmia or abnormalities of vertebrobasilar arteries
• \. History of stroke or TIA
• \. History of cardiac surgery
• \. Contraindications to ablation in the right or left atrium

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

Location

Related Publications (17)

• Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

  PMID: 29562304 BACKGROUND

• Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM, Leyva F, Linde C, Abdelhamid M, Aboyans V, Arbelo E, Asteggiano R, Baron-Esquivias G, Bauersachs J, Biffi M, Birgersdotter-Green U, Bongiorni MG, Borger MA, Celutkiene J, Cikes M, Daubert JC, Drossart I, Ellenbogen K, Elliott PM, Fabritz L, Falk V, Fauchier L, Fernandez-Aviles F, Foldager D, Gadler F, De Vinuesa PGG, Gorenek B, Guerra JM, Hermann Haugaa K, Hendriks J, Kahan T, Katus HA, Konradi A, Koskinas KC, Law H, Lewis BS, Linker NJ, Lochen ML, Lumens J, Mascherbauer J, Mullens W, Nagy KV, Prescott E, Raatikainen P, Rakisheva A, Reichlin T, Ricci RP, Shlyakhto E, Sitges M, Sousa-Uva M, Sutton R, Suwalski P, Svendsen JH, Touyz RM, Van Gelder IC, Vernooy K, Waltenberger J, Whinnett Z, Witte KK. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Europace. 2022 Jan 4;24(1):71-164. doi: 10.1093/europace/euab232. No abstract available.

  PMID: 34455427 BACKGROUND

• Brignole M, Menozzi C, Moya A, Andresen D, Blanc JJ, Krahn AD, Wieling W, Beiras X, Deharo JC, Russo V, Tomaino M, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial. Circulation. 2012 May 29;125(21):2566-71. doi: 10.1161/CIRCULATIONAHA.111.082313. Epub 2012 May 7.

  PMID: 22565936 RESULT

• Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.

  PMID: 33279955 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

• 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 RESULT

• Yao Y, Shi R, Wong T, Zheng L, Chen W, Yang L, Huang W, Bao J, Zhang S. Endocardial autonomic denervation of the left atrium to treat vasovagal syncope: an early experience in humans. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):279-86. doi: 10.1161/CIRCEP.111.966465. Epub 2012 Jan 24.

  PMID: 22275485 RESULT

• Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/JAHA.116.003471.

  PMID: 27402231 RESULT

• Aksu T, Golcuk E, Yalin K, Guler TE, Erden I. Simplified Cardioneuroablation in the Treatment of Reflex Syncope, Functional AV Block, and Sinus Node Dysfunction. Pacing Clin Electrophysiol. 2016 Jan;39(1):42-53. doi: 10.1111/pace.12756. Epub 2015 Oct 26.

  PMID: 26411271 RESULT

• Aksu T, Guler TE, Bozyel S, Yalin K. Selective vagal innervation principles of ganglionated plexi: step-by-step cardioneuroablation in a patient with vasovagal syncope. J Interv Card Electrophysiol. 2021 Apr;60(3):453-458. doi: 10.1007/s10840-020-00757-3. Epub 2020 May 11.

  PMID: 32394104 RESULT

• Debruyne P, Rossenbacker T, Collienne C, Roosen J, Ector B, Janssens L, Charlier F, Vankelecom B, Dewilde W, Wijns W. Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006604. doi: 10.1161/CIRCEP.118.006604.

  PMID: 30354289 RESULT

• Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.

  PMID: 31330187 RESULT

• Piotrowski R, Baran J, Kulakowski P. Cardioneuroablation using an anatomical approach: a new and promising method for the treatment of cardioinhibitory neurocardiogenic syncope. Kardiol Pol. 2018;76(12):1736-1738. doi: 10.5603/KP.a2018.0200. Epub 2018 Oct 19. No abstract available.

  PMID: 30338504 RESULT

• Oh S, Zhang Y, Bibevski S, Marrouche NF, Natale A, Mazgalev TN. Vagal denervation and atrial fibrillation inducibility: epicardial fat pad ablation does not have long-term effects. Heart Rhythm. 2006 Jun;3(6):701-8. doi: 10.1016/j.hrthm.2006.02.020. Epub 2006 Mar 6.

  PMID: 16731474 RESULT

• Pachon M JC, Pachon M EI, Santillana P TG, Lobo TJ, Pachon CTC, Pachon M JC, Albornoz V RN, Zerpa A JC. Simplified Method for Vagal Effect Evaluation in Cardiac Ablation and Electrophysiological Procedures. JACC Clin Electrophysiol. 2015 Oct;1(5):451-460. doi: 10.1016/j.jacep.2015.06.008. Epub 2015 Aug 21.

  PMID: 29759475 RESULT

• Romanov A, Minin S, Breault C, Pokushalov E. Visualization and ablation of the autonomic nervous system corresponding to ganglionated plexi guided by D-SPECT 123I-mIBG imaging in patient with paroxysmal atrial fibrillation. Clin Res Cardiol. 2017 Jan;106(1):76-78. doi: 10.1007/s00392-016-1045-2. Epub 2016 Oct 17. No abstract available.

  PMID: 27752762 RESULT

• 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 RESULT

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

Radiofrequency Ablation

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Piotr Kulakowski, MD PhD

  Postgraduate Centre for Medical Eductaion

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 4, 2022
• Study Start: February 2, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• 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: from 2024
• Access Criteria: personal e-mail contact

Locations

PL (1)