Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

NCT05751330 | Unknown

• 1 other identifier: PCasilino
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Multicenter Italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with CNS who performed severe CNA identified through asystolic pauses identification by implantable loop recorder. The study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the Italian Multidisciplinary Group for the Study of Syncope (GIMSI).

Conditions

Neurally Mediated Syncope

Outcome Measures

Primary Outcomes (1)

• Intrapatient incidence of asystolic episodes before and after cardioneuroablation

  frequency (number and percentage) of asystolic episodes before and after ablation

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Comparison of mean heart rate, before and after cardioneuroablation, incidence of (pre)syncopal episodes before and after CNA and, finally, beat-to beat HR variability during ILR monitoring

  through study completion, an average of 1 year

Study Arms (1)

patients affected by Cardioinhibitory Neurocardiogenic Syncope

EXPERIMENTAL

Procedure: Transcatheter ablation of cardiac ganglionated plexi

Interventions

Transcatheter ablation of cardiac ganglionated plexi PROCEDURE

The ablative procedure involves applying radiofrequency deliveries in the two Right atrium anatomical sites close to the two main ganglionic plexuses of the right atrium: * Inferior-posterior area (site of first ablation) corresponding to the right inferior atrial ganglion located between the inferior vena cava, coronary sinus ostium and near the atrioventricular node * Upper-posterior area (site of second ablation) corresponding to the right superior atrial ganglion located between the superior vena cava and the posterior surface of the right atrium

patients affected by Cardioinhibitory Neurocardiogenic Syncope

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Patients with a clinical diagnosis of neuromediated syncope according to class I criteria of the ESC guidelines, Table 1
• Clinical history of recurrent syncope (≥2 in the last year or ≥3 in the last 2 years), severe, not tolerated by the patient
• Documentation of ≥2 asystolic pauses \>3 sec daytime on ECG monitoring by implantable loop recorder (ILR), with or without syncope
• Refusal by patient to perform pacemaker implantation
• Tilt test is recommended but not mandatory. Patients with negative tilt test are also enrollable. It can be either positive or negative.

You may not qualify if:

• Absence of sinus dysfunction and atrioventricular node disease.
• Absence of structural heart disease
• Possible alternative diagnoses of syncope

Sponsors & Collaborators

• Policlinico Casilino ASL RMB: lead
• Gruppo Italiano Multidisciplinare per lo Studio della Sincope: collaborator

Study Sites (2)

Policlinico Casilino

Rome, Lazio, 00100, Italy

RECRUITING

Policlinico Casilino

Rome, Lazio, 00179, Italy

RECRUITING

Related Publications (16)

• Task Force for the Diagnosis and Management of Syncope; European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); Heart Rhythm Society (HRS); Moya A, Sutton R, Ammirati F, Blanc JJ, Brignole M, Dahm JB, Deharo JC, Gajek J, Gjesdal K, Krahn A, Massin M, Pepi M, Pezawas T, Ruiz Granell R, Sarasin F, Ungar A, van Dijk JG, Walma EP, Wieling W. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. 2009 Nov;30(21):2631-71. doi: 10.1093/eurheartj/ehp298. Epub 2009 Aug 27. No abstract available.

  PMID: 19713422 RESULT

• 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 RESULT

• Sutton R, Petersen ME. The clinical spectrum of neurocardiogenic syncope. J Cardiovasc Electrophysiol. 1995 Jul;6(7):569-76. doi: 10.1111/j.1540-8167.1995.tb00429.x.

  PMID: 8528491 RESULT

• 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

• Soteriades ES, Evans JC, Larson MG, Chen MH, Chen L, Benjamin EJ, Levy D. Incidence and prognosis of syncope. N Engl J Med. 2002 Sep 19;347(12):878-85. doi: 10.1056/NEJMoa012407.

  PMID: 12239256 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

• Scanavacca M, Hachul D, Pisani C, Sosa E. Selective vagal denervation of the sinus and atrioventricular nodes, guided by vagal reflexes induced by high frequency stimulation, to treat refractory neurally mediated syncope. J Cardiovasc Electrophysiol. 2009 May;20(5):558-63. doi: 10.1111/j.1540-8167.2008.01385.x. Epub 2008 Dec 17.

  PMID: 19207753 RESULT

• Armour JA, Murphy DA, Yuan BX, Macdonald S, Hopkins DA. Gross and microscopic anatomy of the human intrinsic cardiac nervous system. Anat Rec. 1997 Feb;247(2):289-98. doi: 10.1002/(SICI)1097-0185(199702)247:23.0.CO;2-L.

  PMID: 9026008 RESULT

• Singh S, Johnson PI, Lee RE, Orfei E, Lonchyna VA, Sullivan HJ, Montoya A, Tran H, Wehrmacher WH, Wurster RD. Topography of cardiac ganglia in the adult human heart. J Thorac Cardiovasc Surg. 1996 Oct;112(4):943-53. doi: 10.1016/S0022-5223(96)70094-6.

  PMID: 8873720 RESULT

• Chiou CW, Eble JN, Zipes DP. Efferent vagal innervation of the canine atria and sinus and atrioventricular nodes. The third fat pad. Circulation. 1997 Jun 3;95(11):2573-84. doi: 10.1161/01.cir.95.11.2573.

  PMID: 9184589 RESULT

• Po SS, Nakagawa H, Jackman WM. Localization of left atrial ganglionated plexi in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1186-9. doi: 10.1111/j.1540-8167.2009.01515.x. Epub 2009 Jun 26.

  PMID: 19563367 RESULT

• Calo L, Rebecchi M, Sette A, Sciarra L, Borrelli A, Scara A, Grieco D, Politano A, Sgueglia M, De Luca L, Martino A, Panattoni G, Golia P, Turrisi OV, Knowles M, Strano S, de Ruvo E. Catheter ablation of right atrial ganglionated plexi to treat cardioinhibitory neurocardiogenic syncope: a long-term follow-up prospective study. J Interv Card Electrophysiol. 2021 Sep;61(3):499-510. doi: 10.1007/s10840-020-00840-9. Epub 2020 Aug 6.

  PMID: 32766945 RESULT

• Rebecchi M, de Ruvo E, Strano S, Sciarra L, Golia P, Martino A, Calo L. Ganglionated plexi ablation in right atrium to treat cardioinhibitory neurocardiogenic syncope. J Interv Card Electrophysiol. 2012 Sep;34(3):231-5. doi: 10.1007/s10840-012-9666-5. Epub 2012 Mar 21. No abstract available.

  PMID: 22434334 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

• Brignole M, Iori M, Solari D, Bottoni N, Rivasi G, Ungar A, Deharo JC, Guieu R. Efficacy of theophylline in patients with syncope without prodromes with normal heart and normal ECG. Int J Cardiol. 2019 Aug 15;289:70-73. doi: 10.1016/j.ijcard.2019.03.043. Epub 2019 Mar 22.

  PMID: 30928258 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

Central Study Contacts

Marco Rebecchi, MD

CONTACT

+393402873746; marcorebecchi3@virgilio.it

Leonardo Calo', MD

CONTACT

+393388589677; leonardocalo.doc@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: January 4, 2023
• First Posted: March 2, 2023
• Study Start: September 20, 2022
• Primary Completion: September 20, 2024
• Study Completion: December 30, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (2)