Cardioneuroablation for treating reflex syncope
Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
This study is testing a new heart procedure called cardioneuroablation to see if it can help people who often faint from reflex syncope feel better than with standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundación de investigación HM Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05513755 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of cardioneuroablation, a novel technique that targets parasympathetic ganglia in the heart, for patients suffering from reflex syncope. The study is a multicenter, randomized, single-blinded trial aiming to enroll 92 patients who have experienced multiple episodes of reflex syncope. Participants will be randomly assigned to receive either the cardioneuroablation intervention or conventional treatment methods. The goal is to determine if this new approach provides better outcomes compared to existing palliative treatments.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented history of reflex syncope and a cardioinhibitory response.
Not a fit: Patients under 18, those with pacemakers, or individuals with significant structural heart disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with reflex syncope by providing a definitive solution rather than just palliative care.
How similar studies have performed: While there have been promising results from prospective series on cardioneuroablation, this is the first randomized study to validate its efficacy against conventional treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with reflex syncope (two or more episodes in the last year) and cardioinhibitory response (documentation of asystole \>3 seconds coinciding with syncope or \>6 seconds outside of syncope or cardioinhibitory response on the tilt test) defined such as heart rate \< 40 bpm for at least 10 seconds or asystolic pause \> 3 seconds Exclusion Criteria: * Patients under 18 years * Any pathology or medical condition that limits survival to less than one year; * Illegal drug use, chronic alcoholism, or total alcohol use \>80 g/d * Participation in a clinical trial conducted with drugs or use of a drug in an experimental state during the year prior to inclusion * Patients institutionalized for chronic treatment, with a lack of autonomy and with the impossibility of carrying out clinical follow-ups * Patients with pacemakers, patients with intrinsic disease of the cardiac conduction system or bundle branch block * Patients with structural heart disease.
Where this trial is running
Madrid
- Teresa Barrio Lopez — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Maria T Barrio-Lopez, MD, PhD
- Email: terebarriol@gmail.com
- Phone: +34917089900
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.