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Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial) (CARDIOSYE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05513755
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : August 26, 2022
Sponsor:
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
Information provided by (Responsible Party):
Teresa Barrio, Fundación de investigación HM

Study Description
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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.


Condition or disease Intervention/treatment Phase
Reflex Syncope Procedure: cardioneuroablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. time to the first syncope [ Time Frame: 12 months ]
    time from the randomization to the first syncope


Secondary Outcome Measures :
  1. number of syncopes during the follow-up period [ Time Frame: 12 months ]
    number of syncopes during the follow-up period


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05513755


Contacts
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Contact: Maria T Barrio-Lopez, MD, PhD +34917089900 ext 2710 terebarriol@gmail.com
Contact: Jesus Almendral, MD, PhD, FESC almendraljesus@gmail.com

Locations
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Spain
Teresa Barrio Lopez Recruiting
Madrid, Spain, 28660
Contact: María T Barrio Lopez, MD, PhD    034917089900 ext 2710    terebarriol@gmail.com   
Contact: Jesus Almendral, MD, PhD, FESC       almendraljesus@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         
Sponsors and Collaborators
Fundación de investigación HM
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Teresa Barrio, principal investigator, Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT05513755    
Other Study ID Numbers: Cardioneuroablation in Syncope
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Barrio, Fundación de investigación HM:
reflex syncope
cardioneuroablation
randomized
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases