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NCT Number: NCT06159764

National Registry of Cardioneuroablation in Recurrent Reflex Syncope

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

Recruiting

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardioneuroablation

Procedure

radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias

Primary outcomes

  1. Recurrence of vasovagal syncope

    Time frame: 12 months

    Number of patients with recurrence

Secondary outcomes

  1. Recurrence of vasovagal syncope in different subgroups

    Time frame: 12 months

    Number of patients with recurrence

  2. Efficacy of cardioneuroablation procedure

    Time frame: 12 months

    Number of asystolic pauses

  3. prevalence of post-ablation pre-syncopal events

    Time frame: 12 months

    Number of post-ablation pre-syncopal events

  4. correlation between ablation sites and epicardial fat pads

    Time frame: 12 months

    spatial correlation between ablation sites and epicardial fat pads

  5. 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]

  6. 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])

  7. Assessment of technical learning curve by centre

    Time frame: 12 months

    procedure time

Study contacts

Contact information is provided by the study sponsor or research team.

Josselin DUCHATEAU

CONTACT

[email protected]

+33 5 57 65 64 71

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CANVAS-R

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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