Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity

Wroclaw Medical University

Status: Completed

Conditions: Syncope, Vasovagal, Neurally-Mediated

Treatments: Procedure: Cardioneuroablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06697145

KB-331/2022

Details and patient eligibility

About

Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consent
• sinus rhythm
• clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope

Exclusion criteria

• pregnancy
• known atropine hypersensitivity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Cardioneuroablation

Experimental group

Treatment:

Procedure: Cardioneuroablation