Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Recruiting now · Not applicable
Conditions studied: Reflex Syncope
In brief
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.
Key facts
- Study ID
- NCT05855603
- Run by
- Institut d'Investigació Biomèdica de Bellvitge
- People needed
- 90
- Starts
- 2023-11-22
- Expected to finish
- 2027-02-22
- Last updated by the study team
- 2024-01-25
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Hospital Universitario de Bellvitge — Barcelona, Spain (enrolling)
- Hospital Universitari General de Castellón — Castellon, Castellón, Spain
- Hospital Universitario Álvaro Cunqueiro de Vigo — Vigo, Pontevedra, Spain
- Hospital del Mar — Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- Hospital Universitari Dr. Josep Trueta — Girona, Spain
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Spain
- Hospital Universitari i Politècnic La Fe — Valencia, Spain
- Hospital Universitario San Juan de Alicante — Sant Joan d'Alacant, Alicante, Spain
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain
Full record on ClinicalTrials.gov
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