Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT06440291

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Led by Centre of Postgraduate Medical Education · Updated on 2025-09-26

100

Participants Needed

1

Research Sites

134 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe, recurrent symptoms due to reflex syncope or recurrent presyncope caused by slow heart rate
  • ECG showing asystole longer than 3 seconds
  • Prior non-pharmacological treatments were ineffective
  • Positive atropine test with sinus rate increase over 30% and no atrio-ventricular block after 2 mg intravenous atropine
  • Signed written consent to participate in the study
Not Eligible

You will not qualify if you...

  • Serious health conditions preventing general anesthesia or cardioneuroablation
  • Sinus arrest or atrio-ventricular block not caused by vagal activity (negative atropine test)
  • Not consenting to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Poland, 04-073

Actively Recruiting

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Research Team

P

Piotr Kulakowski, PhD

CONTACT

A

Anieszka Sikorska, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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