Registry for cardioneuroablation in patients with recurrent vasovagal syncope
National Registry of Cardioneuroablation in Recurrent Reflex Syncope
This study is collecting information to see how well a new treatment called cardioneuroablation works for people with frequent fainting spells caused by vasovagal syncope.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 14 sites (Bron and 13 other locations) |
| Trial ID | NCT06159764 on ClinicalTrials.gov |
What this trial studies
This registry collects data on the effectiveness of cardioneuroablation for treating recurrent vasovagal syncope across multiple centers in France. The study aims to evaluate success rates, compare different techniques, and assist institutions in establishing their own cardioneuroablation programs. By utilizing radiofrequency ablation to target cardiac ganglionated plexi, the registry seeks to answer key questions regarding patient selection, optimal targeting of fat pads, and long-term outcomes of the procedure. The multicenter approach allows for a comprehensive analysis at minimal cost.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with recurrent vasovagal syncope and documented asystolic episodes who are scheduled for a cardioneuroablation procedure.
Not a fit: Patients with contraindications to anticoagulation therapy, cardiac CT, or those with intracardiac thrombus will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment options and outcomes for patients suffering from recurrent vasovagal syncope.
How similar studies have performed: While cardioneuroablation is an emerging technique, this registry approach is relatively novel and aims to fill gaps in existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bron and 13 other locations
- Hôpital Louis Pradel — Bron, France (Recruiting)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU Lille — Lille, France (Not_yet_recruiting)
- Hôpital de la Timone — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Not_yet_recruiting)
- Clinique du Millénaire — Montpellier, France (Recruiting)
- Hôpital Pitié-Salpêtriére — Paris, France (Recruiting)
- Hôpital européen Georges Pompidou — Paris, France (Recruiting)
- Hôpital Haut-Lévèque — Pessac, France (Recruiting)
- CHR Pontchaillou — Rennes, France (Recruiting)
- Centre cardiologique du Nord — Saint-Denis, France (Recruiting)
- Institut ARNAULT TZANCK — Saint-Laurent-du-Var, France (Not_yet_recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Josselin DUCHATEAU — University Hospital, Bordeaux
- Study coordinator: Josselin DUCHATEAU
- Email: josselin.duchateau@chu-bordeaux.fr
- Phone: +33 5 57 65 64 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.