Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a condition called reflex syncope, which is a sudden loss of consciousness that can lead to falls and injuries. The researchers want to find out if a new procedure called cardioneuroablation (CNA) is more effective than traditional cardiac pacing in reducing episodes of this type of syncope. Reflex syncope can greatly affect a person’s quality of life, and current treatments don't always work well, so this study could help improve options for people suffering from this condition.

To participate in this trial, you must be over 40 years old and have experienced at least two episodes of reflex syncope in the past year, or one episode that caused injury. You also need to have specific heart activity patterns that show a link between your heart's slowing down and your fainting spells, which can be confirmed through certain tests. If you join the trial, you will be randomly assigned to receive one of the two treatments being studied. This trial is currently recruiting participants and aims to help find better solutions for those affected by reflex syncope.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged more than 40 years.
• • Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended types of standard treatment.
• • Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope.
• • If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test.
• • Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope.
• • Significantly decreased quality of life due to syncope.
• • Sinus rhythm on ECGs.
• • Obtained written informed consent.
• Exclusion Criteria:
• • Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation.
• • Evidence of structural heart disease.
• • Contraindications to ablation in the right or left atrium.
• • Life expectancy \<12 months.
• • Lacking willingness to comply with the randomization procedure.