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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• severe, recurrent symptoms due to reflex syncope or recurrent presyncope due to slow heart rate

• ECG documented asystole \>3 seconds

• ineffective prior non-pharmacological treatment

• positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine)

• signed written informed consent

Locations
Other Locations
Poland
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
RECRUITING
Warsaw
Contact Information
Primary
Piotr Kulakowski, PhD
kulak@kkcmkp.pl
604455081
Backup
Anieszka Sikorska, PhD
sikorska.agnieszka.anna@gmail.com
604106455
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 100
Treatments
Experimental: cardioneuroablation
Cardioneuroablation procedure as described in the Methods section of the study
Sponsors
Leads: Centre of Postgraduate Medical Education

This content was sourced from clinicaltrials.gov