Reflex SyncopeCARDIOSYENCT05513755
Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)
A study testing cardioneuroablation in people with Reflex Syncope, run by Fundación de investigación HM at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Reflex Syncope
- What is being tested?
- cardioneuroablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jesus Almendral, MD, PhD, FESC contact
Spain1 site, 1 recruiting
- Recruiting
Teresa Barrio Lopez
Madrid, 28660
María T Barrio Lopez, MD, PhD, 034917089900 ext. 2710, terebarriol@gmail.com
Jesus Almendral, MD, PhD, FESC, almendraljesus@gmail.com
About this study
Official title: Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
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.
- Conditions
- Reflex Syncope
- Being tested
- cardioneuroablation
- Keywords
- reflex syncope, cardioneuroablation, randomized
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardioneuroablationProcedure or surgery
Endocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum.
| Study group | Role | What they receive |
|---|---|---|
| Cardioneuroablation | Experimental | Not described Receives: Procedure: cardioneuroablation |
| Conventional treatment (counter-pressurre maneuver, drugs or pacemaker) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first syncope
time from the randomization to the first syncope
Measured: 12 months
Secondary outcomes (1)
number of syncopes during the follow-up period
number of syncopes during the follow-up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start30 Jun 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflex SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Teresa Barrio, Fundación de investigación HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513755
- Sponsor's protocol ID
- Cardioneuroablation in Syncope
- Acronym
- CARDIOSYE
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
- ClinicalTrials.gov ID
- NCT05513755
- Acronym / sponsor ID
- CARDIOSYE / Cardioneuroablation in Syncope
- Conditions
- Reflex Syncope
- Keywords
- reflex syncope, cardioneuroablation, randomized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- 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
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation | Experimental | Procedure: cardioneuroablation |
| Conventional treatment (counter-pressurre maneuver, drugs or pacemaker) | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardioneuroablationEndocardical radiofrequency ablation of vagal ganglia located close to pulmonary veins antra and interatrial septum. | Procedure or surgery | Cardioneuroablation |
Primary outcome
time to the first syncope
Time frame: 12 months
time from the randomization to the first syncope
1 secondary outcome
number of syncopes during the follow-up period
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Almendral, MD, PhD, FESC contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardioneuroablation in people with Reflex Syncope, run by Fundación de investigación HM at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria T Barrio-Lopez, MD, PhD (+34917089900 ext. 2710, terebarriol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to the first syncope (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.