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Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial) (CARDIOSYE)

Primary Purpose

Reflex Syncope

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

cardioneuroablation

About this trial

This is an interventional treatment trial for Reflex Syncope focused on measuring reflex syncope, cardioneuroablation, randomized

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Teresa Barrio LopezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardioneuroablation

Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)

Arm Description

Outcomes

Primary Outcome Measures

time to the first syncope

time from the randomization to the first syncope

Secondary Outcome Measures

number of syncopes during the follow-up period

Full Information

NCT ID

NCT05513755

First Posted

August 22, 2022

Last Updated

August 23, 2022

Sponsor

Fundación de investigación HM

Collaborators

Hospital HM Monteprincipe, Institut Universitari 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 Universitario de Navarra, Complejo Hospitalario Universitario de Albacete, Hospital Universitario Ramon y Cajal, Complejo Hospitalario Universitario de Badajoz

1. Study Identification

Unique Protocol Identification Number

NCT05513755

Brief Title

Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

Acronym

CARDIOSYE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 30, 2022 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundación de investigación HM

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reflex Syncope

Keywords

reflex syncope, cardioneuroablation, randomized

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cardioneuroablation

Arm Type

Experimental

Arm Title

Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

cardioneuroablation

Intervention Description

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

Primary Outcome Measure Information:

Title

time to the first syncope

Description

time from the randomization to the first syncope

Time Frame

12 months

Secondary Outcome Measure Information:

Title

number of syncopes during the follow-up period

Description

number of syncopes during the follow-up period

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria T Barrio-Lopez, MD, PhD

Phone

+34917089900

Ext

2710

terebarriol@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jesus Almendral, MD, PhD, FESC

almendraljesus@gmail.com

Facility Information:

Facility Name

Teresa Barrio Lopez

City

Madrid

ZIP/Postal Code

28660

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

María T Barrio Lopez, MD, PhD

Phone

034917089900

Ext

2710

terebarriol@gmail.com

First Name & Middle Initial & Last Name & Degree

Jesus Almendral, MD, PhD, FESC

almendraljesus@gmail.com

First Name & Middle Initial & Last Name & Degree

Jesus M Almendral, MD, PhD, FESCMPH

First Name & Middle Initial & Last Name & Degree

Angel Moya Mitjans, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jesus Martinez Alday, MD, PhD

First Name & Middle Initial & Last Name & Degree

Carlos A Alvarez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Oscar Alcalde, MD, PhD

First Name & Middle Initial & Last Name & Degree

Nuria Basterra, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jose L Ibañez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alicia Ibañez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Rosa Macias, MD, PhD

First Name & Middle Initial & Last Name & Degree

Miguel Alvarez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jordi Pérez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jaume Francisco, MD, PhD

First Name & Middle Initial & Last Name & Degree

Felipe Rodriguez Entem, MD, PhD

First Name & Middle Initial & Last Name & Degree

Victor Exposito, MD, PhD

First Name & Middle Initial & Last Name & Degree

Pablo E Garcia Granja, MD, PhD

First Name & Middle Initial & Last Name & Degree

Cristina Aguilera, MD, PhD

First Name & Middle Initial & Last Name & Degree

Eusebio Garcia-Izquierdo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sebastian Giacoman, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jose M Lozano, MD, PhD

First Name & Middle Initial & Last Name & Degree

Javier Fernadez-Portales, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sofia Calero, MD, PhD

First Name & Middle Initial & Last Name & Degree

Victor Hidalgo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Larraitz Gaztañaga, MD, PhD

First Name & Middle Initial & Last Name & Degree

Eduardo Franco, MD, PhD

First Name & Middle Initial & Last Name & Degree

Juan M Duran, MD, PhD

First Name & Middle Initial & Last Name & Degree

Andreu Porta-Sanchez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Ivo Roca, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

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