NCT05513755

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 22, 2022

Last Update Submit

August 23, 2022

Conditions

Reflex Syncope

Keywords

reflex syncopecardioneuroablationrandomized

Outcome Measures

Primary Outcomes (1)

  • time to the first syncope

    time from the randomization to the first syncope

    12 months

Secondary Outcomes (1)

  • number of syncopes during the follow-up period

    12 months

Study Arms (2)

Cardioneuroablation

EXPERIMENTAL
Procedure: cardioneuroablation

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

NO INTERVENTION

Interventions

cardioneuroablationPROCEDURE

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

Cardioneuroablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teresa Barrio Lopez

Madrid, 28660, Spain

RECRUITING

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Maria T Barrio-Lopez, MD, PhD

CONTACT

+34917089900terebarriol@gmail.com

Jesus Almendral, MD, PhD, FESC

CONTACT

almendraljesus@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

June 30, 2022

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

August 26, 2022

Record last verified: 2022-08

Locations

ES(1)