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RECRUITING
NCT06440291
NA

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Sponsor: Centre of Postgraduate Medical Education

View on ClinicalTrials.gov

Summary

Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in \> 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people.

Official title: Effects of caRdioneurOablation on Exercise perforMance in Patients With Reflex Asystolic syNcope: The Roman 3 Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-05-02

Completion Date

2025-12-01

Last Updated

2025-09-26

Healthy Volunteers

Yes

Interventions

PROCEDURE

Cardioneuroablation

Cardioneuroablation procedure performed according to the protocol

Locations (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Poland