National Registry of Cardioneuroablation in Recurrent Reflex Syncope (CANVAS-R)

June 12, 2025 updated by: University Hospital, Bordeaux
This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardioneuroablation is an emerging technique used to treat patients with vagally-mediated extrinsic bradycardia. It seems particularly efficient in patients with recurrent vasovagal syncope due to a strong cardioinhibitory effect. The procedure consists in using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias. Key questions concerning this procedure still remain unanswered: 1) What is the success rate of the procedure 2) Which patients will benefit from this technique? 3) Which fat pads should be targeted during the procedure? 4) What is the best way of identifying the location of these fat pads? 5) What are the long-term effects of this procedure? A multicenter registry seems ideal to try to answer these questions at minimal cost

Study Type

Observational

Enrollment (Estimated)

50

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 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with vagally-mediated extrinsic bradycardia

Description

Inclusion Criteria:

  • Patients aged 18 or more
  • Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block.
  • Scheduled cardioneuroablation procedure
  • Estimated residual battery life ≥ 1 year.
  • Patient affiliated to or beneficiary of national health security scheme.
  • Patient who have received an information notice and has not objected to the use of their data in the registry.

Exclusion Criteria:

  • Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease
  • Contraindication to cardiac CT: contrast medium allergies
  • Intracardiac thrombus
  • Patient detained by judicial or administrative decision.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardioneuroablation
Procedure: Cardioneuroablation
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of vasovagal syncope
Time Frame: 12 months
Number of patients with recurrence
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of vasovagal syncope in different subgroups
Time Frame: 12 months
Number of patients with recurrence
12 months
Efficacy of cardioneuroablation procedure
Time Frame: 12 months
Number of asystolic pauses
12 months
prevalence of post-ablation pre-syncopal events
Time Frame: 12 months
Number of post-ablation pre-syncopal events
12 months
correlation between ablation sites and epicardial fat pads
Time Frame: 12 months
spatial correlation between ablation sites and epicardial fat pads
12 months
Assessment of technical learning curve by centre
Time Frame: 12 months
procedure time
12 months
Quality of life of post-ablated patients (Score 1)
Time Frame: 12 months
ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL [better]
12 months
Quality of life of post-ablated patients (Score 2)
Time Frame: 12 months
SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope [better])
12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Josselin DUCHATEAU, University Hospital, Bordeaux

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)

November 27, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/62

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Bradycardia

Clinical Trials on Cardioneuroablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe