Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial) (CARDIOSYE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reflex Syncope
• Intervention / Treatment: Procedure: cardioneuroablation

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria T Barrio-Lopez, MD, PhD; Phone Number: 2710 +34917089900; Email: terebarriol@gmail.com
• Study Contact Backup: Name: Jesus Almendral, MD, PhD, FESC; Email: almendraljesus@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28660
    • Recruiting
    • Teresa Barrio López
    • Contact: Jesus Almendral, MD, PhD, FESC; Email: almendraljesus@gmail.com
    • Contact: María T Barrio Lopez, MD, PhD; Phone Number: 2710 034917089900; Email: terebarriol@gmail.com
    • Principal Investigator: Jesus M Almendral, MD, PhD, FESCMPH
    • Principal Investigator: Angel Moya Mitjans, MD, PhD
    • Principal Investigator: Jesus Martinez Alday, MD, PhD
    • Sub-Investigator: Carlos A Alvarez, MD, PhD
    • Sub-Investigator: Oscar Alcalde, MD, PhD
    • Sub-Investigator: Nuria Basterra, MD, PhD
    • Sub-Investigator: Jose L Ibañez, MD, PhD
    • Sub-Investigator: Alicia Ibañez, MD, PhD
    • Sub-Investigator: Rosa Macias, MD, PhD
    • Sub-Investigator: Miguel Alvarez, MD, PhD
    • Sub-Investigator: Jordi Pérez, MD, PhD
    • Sub-Investigator: Jaume Francisco, MD, PhD
    • Sub-Investigator: Felipe Rodriguez Entem, MD, PhD
    • Sub-Investigator: Victor Exposito, MD, PhD
    • Sub-Investigator: Pablo E Garcia Granja, MD, PhD
    • Sub-Investigator: Cristina Aguilera, MD, PhD
    • Sub-Investigator: Eusebio Garcia-Izquierdo, MD, PhD
    • Sub-Investigator: Sebastian Giacoman, MD, PhD
    • Sub-Investigator: Jose M Lozano, MD, PhD
    • Sub-Investigator: Javier Fernadez-Portales, MD, PhD
    • Sub-Investigator: Sofia Calero, MD, PhD
    • Sub-Investigator: Victor Hidalgo, MD, PhD
    • Sub-Investigator: Larraitz Gaztañaga, MD, PhD
    • Sub-Investigator: Eduardo Franco, MD, PhD
    • Sub-Investigator: Juan M Duran, MD, PhD
    • Sub-Investigator: Andreu Porta-Sanchez, MD, PhD
    • Sub-Investigator: Ivo Roca, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioneuroablation	Procedure: cardioneuroablation; Endocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum.
No Intervention: Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to the first syncope	time from the randomization to the first syncope	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of syncopes during the follow-up period	number of syncopes during the follow-up period	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: randomized; cardioneuroablation; reflex syncope
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: Cardioneuroablation in Syncope

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No