Reflex Syncope
Conditions
Keywords
reflex syncope, cardioneuroablation, randomized
Brief summary
Background: Reflex syncope is a disease of benign etiology but in severe cases it can be disabling and it carries a risk of severe trauma. Today, there is no proven etiological treatment and only palliative treatments are used, namely a change in hygienic and dietary habits, certain drugs or, in the most severe cases, the implantation of a pacemaker. Cardioneuroablation is a novel technique that acts by ablating the parasympathetic ganglia located on the external walls of the atria. Several prospective series with promising results have been published, but there are no randomized studies that have validated its efficacy compared to conventional treatment. Methods: The CARDIOSYRE study is a multicenter, randomized, single-blinded study of patients with reflex syncope. The aim is to recruit, between June 2022 and June 2025, 92 patients with reflex cardioinhibitory syncope in 15 centers and randomize them (1:1 ratio) to two treatment groups: 1) cardioneuroablation intervention; 2) conventional treatment (control group). The primary end-point will be the time to the first syncope and the secondary end-point will be the total incidence of syncope after one year of follow-up. At least 20 recurrences of syncope are expected during a 1-year follow-up. A relative risk of 0.3 and a statistical power of 80% are assumed. The follow-up will be carried out at 3, 6 and 12 months. Cox models will be used to estimate adjusted Hazard ratios.
Interventions
PROCEDUREcardioneuroablation
Endocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum.
Sponsors
Hospital HM Monteprincipe
Fundacion Dexeus
Hospital de Basurto
Hospital Universitario La Paz
Hospital Clínico Universitario de Valladolid
Hospital Universitario Marqués de Valdecilla
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Hospital General Universitario de Alicante
Hospital Clinico Universitario San Cecilio
University Hospital Virgen de las Nieves
Puerta de Hierro University Hospital
Hospital San Pedro de Alcantara
Hospital of Navarra
Complejo Hospitalario Universitario de Albacete
Hospital Universitario Ramon y Cajal
Complejo Hospitalario Universitario de Badajoz
Fundación de investigación HM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to the first syncope | 12 months | time from the randomization to the first syncope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of syncopes during the follow-up period | 12 months | number of syncopes during the follow-up period |
Countries
Spain
Contacts
Primary ContactMaria T Barrio-Lopez, MD, PhD
Backup ContactJesus Almendral, MD, PhD, FESC
Outcome results
None listed