Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

Neurally Mediated Syncope Clinical Trial

— ItalianCNA  

Official title:

Efficacy of Transcatheter Ablation of Ganglionic Plexuses (Cardioneuroablation) in Right Atrium in Patients With Asystolic Neuromediated Syncope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751330
• Other study ID #: PCasilino
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Policlinico Casilino ASL RMB
• Contact: Marco Rebecchi, MD
• Phone: +393402873746
• Email: marcorebecchi3[@]virgilio.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The so called "Cardioneuroablation (CNA)" focused on the endocardial ablation of atrial ganglionated plexi has proven to be efficacy in patients affected by neuro-mediated cardioinhibitory syncope (NCS). No center currently has sufficient case series to establish long-term efficacy and safety results, for which a multicenter interventional study is therefore needed.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Absence of sinus dysfunction and atrioventricular node disease.

• Absence of structural heart disease

• Possible alternative diagnoses of syncope

Related Conditions & MeSH terms

• Neurally Mediated Syncope
• Syncope
• Syncope, Vasovagal

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	Policlinico Casilino	Roma	Lazio
Italy	Policlinico Casilino	Rome	Lazio

Sponsors (2)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB	Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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. — View Citation

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. — View Citation

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 mediat — View Citation

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 managemen — View Citation

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 a — View Citation

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 cardioinhi — View Citation

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. — View Citation

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 Gu — View Citation

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/ — View Citation

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. — View Citation

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. Epu — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 J — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	intrapatient comparison of mean heart rate (bpm), beat-to-beat variability of heart rate, before and after CNA.	through study completion, an average of 1 year