Cardioneuroablation for Reflex Syncope and Exercise Capacity

Launched by CENTRE OF POSTGRADUATE MEDICAL EDUCATION · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Cardioneuroablation (CNA) for individuals who experience reflex syncope, which is a temporary loss of consciousness due to a sudden drop in heart rate. The study aims to understand how this procedure affects patients' exercise capacity and overall fitness one year after the treatment. While CNA has been effective for over 80% of patients in relieving symptoms, there are concerns about potential side effects, such as an increased heart rate during exercise. Researchers will compare the exercise capacity of patients who undergo CNA with healthy volunteers to see if there are any significant differences.

To be eligible for this trial, participants should have severe and recurring symptoms of reflex syncope, documented instances of their heart stopping for over three seconds, and should not have benefited from previous non-drug treatments. They also need to give their consent to participate. Those who join the study will undergo a special exercise test before the treatment and again one year later to assess their fitness levels. Importantly, this is a chance for patients to contribute to valuable research that could help improve treatment options for others with similar conditions.

Gender

ALL

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