Comparing pacemaker therapy and cardioneuroablation for reflex syncope

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of cardioneuroablation (CNA) compared to permanent pacemaker therapy in patients suffering from cardioinhibitory reflex syncope. Reflex syncope is a common condition that can lead to injuries and significantly impact quality of life. The trial aims to enroll patients over 40 years old who have experienced recurrent syncope episodes and have shown a correlation between bradycardia and syncope. Participants will be monitored to assess which treatment provides better outcomes in reducing syncope episodes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Bellvitge
  Barcelona, Spain Recruiting
• Hospital Universitario San Juan de Alicante
  Sant Joan d'Alacant, Alicante, Spain Not yet recruiting
• Hospital Universitari General de Castellón
  Castellon, Castellón, Spain Not yet recruiting
• Hospital Universitario Álvaro Cunqueiro de Vigo
  Vigo, Pontevedra, Spain Not yet recruiting
• Hospital del Mar
  Barcelona, Spain Not yet recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Not yet recruiting

Study contacts

• Study coordinator: Rodolfo San Antonio, MD, PhD
• Email: rsanantonio@bellvitgehospital.cat
• Phone: 932607500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.