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RecruitingNCT05513755CARDIOSYEUpdated Aug 26, 2022

Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

An interventional study of cardioneuroablation in Reflex Syncope, sponsored by Fundación de investigación HM. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Fundación de investigación HM · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Reflex Syncope

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Keywords

  • reflex syncope
  • cardioneuroablation
  • randomized
03

In context

Syncope, Vasovagal

88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.

This study's planned enrollment of 92 is above the median of 59 across 58 interventional studies indexed under Syncope, Vasovagal.

Browse Syncope, Vasovagal studies →

Lead sponsor

Fundación de investigación HM is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Cardioneuroablation

    Procedure: cardioneuroablation

  • No intervention
    Conventional treatment (counter-pressurre maneuver, drugs or pacemaker)

Interventions

  • Procedurecardioneuroablation

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

06

What researchers measure

Primary outcomes

  1. time to the first syncope

    time from the randomization to the first syncope

    Time frame: 12 months

Secondary outcomes

  1. number of syncopes during the follow-up period

    number of syncopes during the follow-up period

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Teresa Barrio Lopez
    Madrid, 28660, Spain
    Recruiting
    • María T Barrio Lopez, MD, PhD · Contactterebarriol@gmail.com · 034917089900
    • Jesus Almendral, MD, PhD, FESC · Contactalmendraljesus@gmail.com
    • Jesus M Almendral, MD, PhD, FESCMPH · Principal investigator
    • Angel Moya Mitjans, MD, PhD · Principal investigator
    • Jesus Martinez Alday, MD, PhD · Principal 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 · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Jun 2025, 36 months after the start.

Of 29 interventional studies with no phase under Syncope, Vasovagal, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15. This study's planned 36 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2022
First posted
Aug 24, 2022
StartActual
Jun 30, 2022
Primary completionEst.
Jun 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Aug 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05513755
Lead sponsor
Fundación de investigación HM
Collaborators
Hospital HM Monteprincipe, Fundacion 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 of Navarra, Complejo Hospitalario Universitario de Albacete, Hospital Universitario Ramon y Cajal, Complejo Hospitalario Universitario de Badajoz
Responsible party
Teresa Barrio (principal investigator, Fundación de investigación HM) — Principal investigator
First posted
Aug 24, 2022
Start date
Jun 30, 2022
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 26, 2022

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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