Syncope, Vasovagal, Neurally-MediatedNCT06697145
Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
A study testing Cardioneuroablation in people with Syncope, Vasovagal, Neurally-Mediated, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Syncope, Vasovagal, Neurally-Mediated
- 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
- 12 participants
- Where
- 1 sitePoland
- Study dates
- 23 Nov 2021to 31 Dec 2024
- 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
- signed informed consent
- sinus rhythm
- clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
Who cannot join
- pregnancy
- known atropine hypersensitivity
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Being tested
- Cardioneuroablation
- 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
Ablation of parasympathetic ganglia of the heart
| Study group | Role | What they receive |
|---|---|---|
| Cardioneuroablation | Experimental | Not described Receives: Procedure: Cardioneuroablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of parasympathetic denervation (%)
Measured: 12 months
Secondary outcomes (5)
Change in heart rate (beats/min)
Measured: 12 months
Change in heart rate variability (ms)
Measured: 12 months
Change in cardiac barosensitivity (ms/mmHg)
Measured: 12 months
Change in hypoxic heart rate response (beats/min SpO2)
Measured: 12 months
Time to recurrence of syncopal event (days
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 posted20 Nov 2024
- Study start23 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, Vasovagal, Neurally-MediatedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Niewinski, MD, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697145
- Sponsor's protocol ID
- KB-331/2022
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
- ClinicalTrials.gov ID
- NCT06697145
- Acronym / sponsor ID
- KB-331/2022
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Nov 2024 (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.
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation | Experimental | Procedure: Cardioneuroablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- sinus rhythm
- clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
Key exclusion criteria (2 listed)
- pregnancy
- known atropine hypersensitivity
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 |
|---|---|---|
| CardioneuroablationAblation of parasympathetic ganglia of the heart | Procedure or surgery | Cardioneuroablation |
Primary outcome
Change in degree of parasympathetic denervation (%)
Time frame: 12 months
5 secondary outcomes
Change in heart rate (beats/min)
Time frame: 12 months
Change in heart rate variability (ms)
Time frame: 12 months
Change in cardiac barosensitivity (ms/mmHg)
Time frame: 12 months
Change in hypoxic heart rate response (beats/min SpO2)
Time frame: 12 months
Time to recurrence of syncopal event (days
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syncope, Vasovagal, Neurally-Mediated, run by Wroclaw Medical University at 1 site in Poland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Mar 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of parasympathetic denervation (%) (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 30 Mar 2025.