Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Spain
Teresa Barrio Lopez
Recruiting
Madrid
Contact Information
Primary
Maria T Barrio-Lopez, MD, PhD
terebarriol@gmail.com
+34917089900
Backup
Jesus Almendral, MD, PhD, FESC
almendraljesus@gmail.com
Time Frame
Start Date: June 30, 2022
Estimated Completion Date: December 31, 2025
Participants
Target number of participants: 92
Treatments
Experimental: Cardioneuroablation
No Intervention: Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)
Authors
Angel Moya Mitjans, Alicia Ibañez, Sebastian Giacoman, Miguel Alvarez, Larraitz Gaztañaga, Jose L Ibañez, Victor Exposito, Jaume Francisco, Carlos A Alvarez, Nuria Basterra, Oscar Alcalde, Juan M Duran, Eusebio Garcia-Izquierdo, Andreu Porta-Sanchez, Pablo E Garcia Granja, Cristina Aguilera, Javier Fernadez-Portales, Rosa Macias, Jose M Lozano, Jesus Martinez Alday, Sofia Calero, Victor Hidalgo, Felipe Rodriguez Entem, Jordi Pérez, Eduardo Franco, Jesus M Almendral, Ivo Roca
Sponsors
Collaborators: Hospital HM Monteprincipe, Hospital San Pedro de Alcantara, University Hospital Virgen de las Nieves, Hospital Universitario de Navarra, Hospital Universitario Marqués de Valdecilla, Hospital de Basurto, Institut Universitari Dexeus, Puerta de Hierro University Hospital, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Alicante, Hospital Universitario La Paz, Hospital Clínico Universitario de Valladolid, Hospital Clinico Universitario San Cecilio, Complejo Hospitalario Universitario de Badajoz, Complejo Hospitalario Universitario de Albacete, Hospital Vall d'Hebron, Hospital Clinic of Barcelona
Leads: Fundación de investigación HM

This content was sourced from clinicaltrials.gov

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