National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial, called the National Registry of Cardioneuroablation in Recurrent Reflex Syncope, is studying a treatment called cardioneuroablation for people who experience frequent fainting spells, known as vasovagal syncope. The goal is to gather information from various centers in France about how well this procedure works and to compare different techniques used. By collecting this data, the researchers hope to help hospitals start their own programs for treating this condition.

To participate, individuals need to be at least 18 years old and have had at least two fainting episodes in the past year, with specific heart pauses recorded during those events. Participants must also be scheduled for the cardioneuroablation procedure and should not have any major health issues that would prevent them from undergoing the treatment. Anyone who joins the study can expect their health information to be collected and used to improve future treatments for vasovagal syncope. It's important to note that participants will need to give their consent for their data to be included in the registry.

Gender

ALL

Eligibility 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.