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Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients (ItalianCNA)

Primary Purpose

Neurally Mediated Syncope

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transcatheter ablation of cardiac ganglionated plexi
Sponsored by
Policlinico Casilino ASL RMB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurally Mediated Syncope

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Policlinico CasilinoRecruiting
  • Policlinico CasilinoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients affected by Cardioinhibitory Neurocardiogenic Syncope

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 4, 2023
Last Updated
February 20, 2023
Sponsor
Policlinico Casilino ASL RMB
Collaborators
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
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1. Study Identification

Unique Protocol Identification Number
NCT05751330
Brief Title
Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients
Acronym
ItalianCNA
Official Title
Efficacy of Transcatheter Ablation of Ganglionic Plexuses (Cardioneuroablation) in Right Atrium in Patients With Asystolic Neuromediated Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Casilino ASL RMB
Collaborators
Gruppo Italiano Multidisciplinare per lo Studio della Sincope

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurally Mediated Syncope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients affected by Cardioinhibitory Neurocardiogenic Syncope
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Transcatheter ablation of cardiac ganglionated plexi
Intervention Description
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
Primary Outcome Measure Information:
Title
Intrapatient incidence of asystolic episodes before and after cardioneuroablation
Description
frequency (number and percentage) of asystolic episodes before and after ablation
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
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
Description
intrapatient comparison of mean heart rate (bpm), beat-to-beat variability of heart rate, before and after CNA.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Rebecchi, MD
Phone
+393402873746
Email
marcorebecchi3@virgilio.it
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Calo', MD
Phone
+393388589677
Email
leonardocalo.doc@gmail.com
Facility Information:
Facility Name
Policlinico Casilino
City
Roma
State/Province
Lazio
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Rebecchi
Phone
+393402873746
Email
marcorebecchi3@virgilio.it
Facility Name
Policlinico Casilino
City
Rome
State/Province
Lazio
ZIP/Postal Code
00179
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Rebecchi, MD
Phone
+393402873746
Email
marcorebecchi3@virgilio.it
First Name & Middle Initial & Last Name & Degree
Leonardo Rebecchi, MD
Email
leonardocalo.doc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study envisages the subsequent activation of other participating centres to recruit and enrol patients to undergo the Cardioneuroablation procedure
Citations:
PubMed Identifier
19713422
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 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.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
8528491
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.
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Citation
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Citation
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Citation
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Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

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