Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

Reflex Syncope Clinical Trial

— CARDIOSYE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513755
• Other study ID #: Cardioneuroablation in Syncope
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Fundación de investigación HM
• Contact: Maria T Barrio-Lopez, MD, PhD
• Phone: +34917089900
• Email: terebarriol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reflex Syncope
• Syncope
• Syncope, Vasovagal

Intervention

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

Locations

Country	Name	City	State
Spain	Teresa Barrio Lopez	Madrid

Sponsors (18)

Lead Sponsor

Collaborator

Fundación de investigación HM

Complejo Hospitalario Universitario de Albacete, Complejo Hospitalario Universitario de Badajoz, Hospital Clinic of Barcelona, Hospital Clínico Universitario de Valladolid, Hospital Clinico Universitario San Cecilio, Hospital de Basurto, Hospital General Universitario de Alicante, Hospital HM Monteprincipe, Hospital San Pedro de Alcantara, Hospital Universitario de Navarra, Hospital Universitario La Paz, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Ramon y Cajal, Hospital Vall d'Hebron, Institut Universitari Dexeus, Puerta de Hierro University Hospital, University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to the first syncope	time from the randomization to the first syncope	12 months
Secondary	number of syncopes during the follow-up period	number of syncopes during the follow-up period	12 months