Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients
NCT ID: NCT05751330
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2022-09-20
2024-12-30
Brief Summary
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Detailed Description
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The aim of the study will be to evaluate the efficacy and safety of CNA focused in NCS patients. The ablation procedure, consists of radiofrequency delivering at right atrial anatomic sites where the underlying presence of GP clusters is regarded as highly probable: 1) the inferior-posterior area (first ablation site): inferior right GP placed between inferior vena cava, coronary sinus ostium and near the atrio-ventricular groove, 2) the superior-posterior area (second ablation site): superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients affected by Cardioinhibitory Neurocardiogenic Syncope
Transcatheter ablation of cardiac ganglionated plexi
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
Interventions
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Transcatheter ablation of cardiac ganglionated plexi
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Absence of structural heart disease
* Possible alternative diagnoses of syncope
18 Years
60 Years
ALL
Yes
Sponsors
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Gruppo Italiano Multidisciplinare per lo Studio della Sincope
OTHER
Policlinico Casilino ASL RMB
OTHER
Responsible Party
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Leonardo Calò, MD
Professor
Locations
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Policlinico Casilino
Rome, Lazio, Italy
Policlinico Casilino
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PCasilino
Identifier Type: -
Identifier Source: org_study_id
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