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Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial) (CARDIOSYE)

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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

Tracking Information
First Submitted Date  ICMJE August 22, 2022
First Posted Date  ICMJE August 24, 2022
Last Update Posted Date August 26, 2022
Actual Study Start Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2022)		 time to the first syncope [ Time Frame: 12 months ]
time from the randomization to the first syncope
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2022)		 number of syncopes during the follow-up period [ Time Frame: 12 months ]
number of syncopes during the follow-up period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)
Official Title  ICMJE Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Reflex Syncope
Intervention  ICMJE Procedure: cardioneuroablation
Endocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum.
Study Arms  ICMJE
  • Experimental: Cardioneuroablation
    Intervention: Procedure: cardioneuroablation
  • No Intervention: Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2022)		 92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria T Barrio-Lopez, MD, PhD +34917089900 ext 2710 terebarriol@gmail.com
Contact: Jesus Almendral, MD, PhD, FESC almendraljesus@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05513755
Other Study ID Numbers  ICMJE Cardioneuroablation in Syncope
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Teresa Barrio, Fundación de investigación HM
Original Responsible Party Teresa Barrio, Fundación de investigación HM, MD, PhD
Current Study Sponsor  ICMJE Fundación de investigación HM
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Fundación de investigación HM
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP