Comparing pacemaker therapy and cardioneuroablation for reflex syncope
Recurrent Cardioinhibitory Reflex Syncope. PermANent PAcemaker Therapy or CardionEuroablation? A Multicenter RAndomized Clinical Trial
This study is testing whether a new treatment called cardioneuroablation works better than a pacemaker for people over 40 who have frequent fainting spells caused by slow heart rates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 10 sites (Sant Joan d'Alacant, Alicante and 9 other locations) |
| Trial ID | NCT05855603 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 40 years old with a history of frequent reflex syncope episodes that have not responded to standard treatments.
Not a fit: Patients with intrinsic sinus or atrioventricular nodal disease requiring a pacemaker for other reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from reflex syncope, potentially improving their quality of life and reducing the risk of injury.
How similar studies have performed: Previous studies have shown promising results for both cardioneuroablation and pacemaker therapy in treating reflex syncope, indicating that this approach is based on emerging evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sant Joan d'Alacant, Alicante and 9 other locations
- 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)
- Hospital Universitario de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital Universitari Dr. Josep Trueta — Girona, Spain (Not_yet_recruiting)
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Spain (Not_yet_recruiting)
- Hospital Universitari i Politècnic La Fe — Valencia, Spain (Not_yet_recruiting)
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Rodolfo San Antonio, MD, PhD
- Email: rsanantonio@bellvitgehospital.cat
- Phone: 932607500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.