Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06440291 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Study acronym: Roman3
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 1, 2025 → Nov 1, 2026
See other at-risk trials from Centre of Postgraduate Medical Education

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 1, 2025 to Nov 1, 2026 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 6 of 6 entries
  2. Minor Primary and study completion dates: Sep 1, 2025 to Dec 1, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06440291
Lead Sponsor Centre of Postgraduate Medical Education
Conditions
(from sponsor)
Syncope, Vasovagal
Related terms Syncope, Syncope, Vasovagal
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov