NCT06440291 Cardioneuroablation for Reflex Syncope and Exercise Capacity
| NCT ID | NCT06440291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre of Postgraduate Medical Education |
| Condition | Syncope, Vasovagal |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-05-02 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * serious comorbidities precluding general anaesthesia and cardioneuroablation * non-functional sinus arrest or atrio-ventricular block (negative atropine test) * lack of consent to participate in the study
Contact & Investigator
Roman Piotrowski, PhD
STUDY DIRECTOR
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Frequently Asked Questions
Who can join the NCT06440291 clinical trial?
This trial is open to participants of all sexes, studying Syncope, Vasovagal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06440291 currently recruiting?
Yes, NCT06440291 is actively recruiting participants. Contact the research team at kulak@kkcmkp.pl for enrollment information.
Where is the NCT06440291 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06440291 clinical trial?
NCT06440291 is sponsored by Centre of Postgraduate Medical Education. The principal investigator is Roman Piotrowski, PhD at Department of Cardiology, Postgraduate Medical School, Grochowski Hospital. The trial plans to enroll 100 participants.