Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients (ItalianCNA)

February 20, 2023 updated by: Leonardo Calò, MD, Policlinico Casilino ASL RMB

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients affected by Cardioinhibitory Neurocardiogenic Syncope
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrapatient incidence of asystolic episodes before and after cardioneuroablation
Time Frame: through study completion, an average of 1 year
frequency (number and percentage) of asystolic episodes before and after ablation
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Casilino ASL RMB

Collaborators

Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Anticipated)

September 20, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCasilino

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study envisages the subsequent activation of other participating centres to recruit and enrol patients to undergo the Cardioneuroablation procedure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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