Syncope, VasovagalCANVAS-RNCT06159764
National Registry of Cardioneuroablation in Recurrent Reflex Syncope
An observational study of Syncope, Vasovagal and Bradycardia, run by University Hospital, Bordeaux at 14 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Syncope, Vasovagal, Bradycardia, Heart Arrest
- What is being tested?
- Cardioneuroablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 14 sitesFrance
- Study dates
- 27 Nov 2024to 31 Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with vagally-mediated extrinsic bradycardia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Hôpital Louis Pradel
Bron, 69500
Kévin GARDEY, kevin.gardey@chu-lyon.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Saer ABU ALRUB, sabualrub@chu-clermontferrand.fr
- Not yet recruiting
CHU Lille
Lille, 59000
Cédric KLEIN, cedric.klein@chru-lille.fr
- Recruiting
Hôpital de la Timone
Marseille, 13385
Baptiste MAILLE, baptiste.maille@ap-hm.fr
- Not yet recruiting
CHU de Montpellier
Montpellier, 34295
Mathieu GRANIER, m-granier@chu-montpellier.fr
- Recruiting
Clinique du Millénaire
Montpellier, 34960
Nicolas CLEMENTY, nclementy@yahoo.fr
- Recruiting
Hôpital Pitié-Salpêtriére
Paris, 75013
Nicolas BADENCO, nicolas.badenco@aphp.fr
- Recruiting
Hôpital européen Georges Pompidou
Paris, 75908
Pierre BAUDINAUD, pierre.baudinaud@aphp.fr
- Recruiting
Hôpital Haut-Lévèque
Pessac, 33604
Josselin Duchateau
- Recruiting
CHR Pontchaillou
Rennes, 35033
Raphaël MARTINS, raphael.martins@chu-rennes.fr
- Recruiting
Centre cardiologique du Nord
Saint-Denis, 93200
William ESCANDE, w.escande@ccn.fr
- Not yet recruiting
Institut ARNAULT TZANCK
Saint-Laurent-du-Var, 06700
Hugo MARCHAND, h.marchand@tzanck.org
- Recruiting
Clinique Pasteur
Toulouse, 31076
Quentin VOGLIMACCI, qvoglimacci@clinique-pasteur.com
- Recruiting
CHU de Toulouse
Toulouse, 31400
Philippe MAURY, maury.p@chu-toulouse.fr
About this study
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
Read the 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
- Conditions
- Syncope, Vasovagal, Bradycardia, Heart Arrest
- Being tested
- Cardioneuroablation
- Keywords
- cardioneuroablation, vasovagal syncope, registry
- Medical subject headings
- Syncope, Vasovagal, Bradycardia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioneuroablationProcedure or surgery
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias
| Study group | Role | What they receive |
|---|---|---|
| Cardioneuroablation | Cardioneuroablation Receives: Procedure: Cardioneuroablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of vasovagal syncope
Number of patients with recurrence
Measured: 12 months
Secondary outcomes (7)
Recurrence of vasovagal syncope in different subgroups
Number of patients with recurrence
Measured: 12 months
Efficacy of cardioneuroablation procedure
Number of asystolic pauses
Measured: 12 months
prevalence of post-ablation pre-syncopal events
Number of post-ablation pre-syncopal events
Measured: 12 months
correlation between ablation sites and epicardial fat pads
spatial correlation between ablation sites and epicardial fat pads
Measured: 12 months
Quality of life of post-ablated patients (Score 1)
ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL [better]
Measured: 12 months
Quality of life of post-ablated patients (Score 2)
SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope [better])
Measured: 12 months
Assessment of technical learning curve by centre
procedure time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Nov 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josselin DUCHATEAU, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159764
- Sponsor's protocol ID
- CHUBX 2022/62
- Acronym
- CANVAS-R
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Cardioneuroablation in Recurrent Reflex Syncope
- ClinicalTrials.gov ID
- NCT06159764
- Acronym / sponsor ID
- CANVAS-R / CHUBX 2022/62
- Conditions
- Syncope, Vasovagal, Bradycardia, Heart Arrest
- Keywords
- cardioneuroablation, vasovagal syncope, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation | – | Procedure: CardioneuroablationCardioneuroablation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with vagally-mediated extrinsic bradycardia
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardioneuroablationradiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias | Procedure or surgery | Cardioneuroablation |
Primary outcome
Recurrence of vasovagal syncope
Time frame: 12 months
Number of patients with recurrence
7 secondary outcomes
Recurrence of vasovagal syncope in different subgroups
Time frame: 12 months
Efficacy of cardioneuroablation procedure
Time frame: 12 months
prevalence of post-ablation pre-syncopal events
Time frame: 12 months
correlation between ablation sites and epicardial fat pads
Time frame: 12 months
Quality of life of post-ablated patients (Score 1)
Time frame: 12 months
Quality of life of post-ablated patients (Score 2)
Time frame: 12 months
Assessment of technical learning curve by centre
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josselin DUCHATEAU principal investigator
University Hospital, Bordeaux
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, Vasovagal and Bradycardia, run by University Hospital, Bordeaux at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josselin DUCHATEAU (+33 5 57 65 64 71, josselin.duchateau@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of vasovagal syncope (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.