Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

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.

Conditions

• Reflex Syncope

Interventions

PROCEDURE

cardioneuroablation

Endocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum.

Sponsors & Collaborators

• Hospital HM Monteprincipe

  collaborator UNKNOWN

• Fundacion Dexeus

  collaborator OTHER

• Hospital de Basurto

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Clinico Universitario San Cecilio

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Puerta de Hierro University Hospital

  collaborator OTHER

• Hospital San Pedro de Alcantara

  collaborator OTHER

• Hospital of Navarra

  collaborator OTHER

• Complejo Hospitalario Universitario de Albacete

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Complejo Hospitalario Universitario de Badajoz

  collaborator OTHER

• Fundación de investigación HM

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• Spain

Study Locations