Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorInstitut d'Investigació Biomèdica de Bellvitge

About this trial

Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness. In certain patients, cardiac pacing seem to be beneficial. More recently cardioneuroablation (CNA) has emerged as a novel therapy for reflex syncope. The investigators aim to determine whether CNA is more effective than cardiac pacing at reducing the rate of cardioinhibitory-type reflex syncope.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cardioneuroablation
  • Permanent pacemaker therapy

Treatment groups

90 Participants
are divided into 2 treatment groups