Syncope, NeurogenicCardNMH3NCT04755101
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
A study testing EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation. and EPS, electro-anatomical mapping, and pharmacological evaluation. in people with Syncope, Neurogenic and Syncope, run by Imelda Hospital, Bonheiden at 3 sites in Belgium.
Trial summary
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Syncope, Neurogenic, Syncope
- What is being tested?
- EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation. and EPS, electro-anatomical mapping, and pharmacological evaluation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesBelgium
- Study dates
- 24 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be in sinus rhythm and have ≥3 syncopes during the last 18 months* and a previous positive tilt table test (TTT) with a cardioinhibitory or mixed response (VASIS I, IIA or IIB classification).
- syncopes occurring during TTT are not taken into account
- Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
Who cannot join
- <14 years age
- Any unstable medical condition, life expectancy <12 months
- Inability to provide consent or undergo follow-up
- Syncope due to a non-cardiac disease or due to an advanced neuropathy
- Moderate to severe valvular or subvalvular aortic stenosis or mitral stenosis
- Overt heart failure or left ventricular ejection fraction <45%
Show all 16Show fewer
- Current pregnancy
- Chronotropic negative medications unless judged mandatory
- 4 g amiodarone intake during the 2 months preceding enrollment
- Alternating RBBB and LBBB, HV interval >70 ms
- LBBB, bifascicular block (RBBB + LAHB, RBBB + LPHB)
- PR interval permanently >240 ms
- Pacemaker or automated implantable cardioverter defibrillator device
- Permanent AF, PAF or electrical cardioversion during the last 6 months
- Channelopathy
- Tilt table test with VASIS III response or with VASIS II response and AV-Block
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
Imeldaziekenhuis
Bonheiden, 2820
Philippe Debruyne, MD, philippe.debruyne@skynet.be
Philippe Debruyne, MD
- Not yet recruiting
Algemeen Ziekenhuis Sint Jan
Bruges, 8000
Jean-Benoît le Polain de Waroux, MD,PhD, 0032478234732, Jblpdw@hotmail.com
Jean-Benoît le Polain de Waroux, MD,PhD
- Recruiting
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000
Peter Haemers, MD,PhD, 0032474300566, peter.haemers@uzleuven.be
Peter Haemers, MD,PhD
About this study
Official title: Cardio-Neuromodulation in Humans, 3th Study
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope (NMS).
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Read more
Two-third of the patients will be randomized to the active arm and one-third to the control arm (sham).
The study procedure is described in the 'detailed description' and 'intervention description'.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If syncope-free survival (primary endpoint) is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
Read the detailed description
The efficacy of therapeutic strategies mentioned in the guidelines for patients with neurally mediated syncope (NMS) is limited. The first clinical study on cardiac denervation in humans was published in 2005. Derived from this first method, different approaches to cardioneuroablation (CNA) to treat NMS have been published. Such ablations are complex, bi-atrial, and extensive. Cardio-neuromodulation (CardNM) is a less extensive and right-sided approach to CNA, based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus. Evidence from a single-center, non-randomized, unblinded trial showed that CardNM was associated with a reduction in syncope burden exceeding 90%.
This third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope.
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Two-thirds of the patients will be randomized to the active arm and one-third to the control arm (sham).
In all patients, the endocardial site to potentially target during ablation will be annotated before the procedure by a target line (TL) on a computed tomographic image of the heart imported into the CARTO system (Biosense Webster, Diamond Bar, CA), as detailed in the 'intervention description'.
The study procedure will be performed under general anesthesia according to a standardized protocol. In all patients, a diagnostic electrophysiology study (EPS) and electroanatomical mapping of the right atrium and the surrounding veins will be performed first. This image will be merged with the CT image and the TL will be visible. Randomization will be performed electronically at this stage of the procedure.
In patients assigned to the active arm, the TL will be targeted by ablation as detailed in the intervention description'.
The ablation procedure is considered complete when one of the following conditions is fulfilled:
- 10 radiofrequency applications have been delivered;
- After 5 radiofrequency applications, the P-P interval is <70% of the baseline procedural P-P interval and remains >550 ms 5 min after the last radiofrequency application;
- ≥5 radiofrequency applications have been delivered and the operator estimates that no additional P-P interval shortening will be obtained by additional radiofrequency applications;
- 3 radiofrequency applications have been delivered and the P-P interval is <550 ms after the last radiofrequency application and remains stable after 5 min of waiting.
In all patients, a pharmacological evaluation and new diagnostic EPS will be performed to further evaluate the sinus node and atrioventricular nodal intrinsic activity at the end of the procedure, either after the diagnostic part of the procedure in the sham group or after the ablation in the active arm.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires completed at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If the syncope-free survival, the primary endpoint of the study, is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
- Conditions
- Syncope, Neurogenic, Syncope
- Being tested
- EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation., EPS, electro-anatomical mapping, and pharmacological evaluation.
- Keywords
- cardioneuroablation, cardio-neuromodulation, ganglionated plexi, right-anterior ganglionated plexus, ablation
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.Procedure or surgery
EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. Sequential ablations will be delivered along theTL until the procedure endpoint is reached. Pharmacological evaluation.
EPS, electro-anatomical mapping, and pharmacological evaluation.Procedure or surgery
Also called EPS, electro-anatomical mapping, no ablation, and pharmacological evaluation.
EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. No ablation is performed (sham). Pharmacological evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Righ-sided ARGP ablation | Active comparator | two-thirds of the patients will be randomized to procedural arm A: a diagnostic evaluation followed by cardio-neuromodulation (CardNM) and a pharmacological evaluation Receives: Procedure: EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation. |
| Placebo | Sham comparator | one-third of the patients will be randomized to procedural arm B: a diagnostic evaluation followed by a pharmacological evaluation. Receives: Procedure: EPS, electro-anatomical mapping, and pharmacological evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncope free survival
The primary efficacy endpoint is the number of days elapsed from study procedure to first syncope recurrence or to study close-out.
Measured: From date of randomization until the date of first syncope recurrence, assessed up to 12-month follow-up.
Secondary outcomes (4)
Syncope burden
Corrected cumulative number of syncope episodes
Measured: 1-, 3-, 6- and 12-month follow-up.
Number of beats with prespecified P-P intervals
Mean number of beats with prespecified P-P intervals over 24-h
Measured: 1-, 3- and 6-month follow-up.
Heart rate variability
Standard deviation of the average NN (SDNN)
Measured: 1-, 3- and 6-month follow-up.
Quality of life scale based on the questionnaire 'Impact of Syncope on Quality of Life (ISQL)
Comparison of scores; higher scores mean a better outcome.
Measured: 1-, 3-, 6- and 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start24 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, NeurogenicStudies 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
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imelda Hospital, Bonheiden
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, AZ Sint-Jan AV, Biosense Webster, Inc., Trium Clinical Consulting
- Responsible party
- Principal investigator, Philippe Debruyne, Imelda Hospital, Bonheiden
- Investigators
- Philippe Debruyne, MD, Principal investigator, Imeldaziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755101
- Sponsor's protocol ID
- B3222020000229
- Acronym
- CardNMH3
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Neuromodulation in Humans, 3th Study
- ClinicalTrials.gov ID
- NCT04755101
- Acronym / sponsor ID
- CardNMH3 / B3222020000229
- Conditions
- Syncope, Neurogenic, Syncope
- Keywords
- cardioneuroablation, cardio-neuromodulation, ganglionated plexi, right-anterior ganglionated plexus, ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Imelda Hospital, BonheidenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, AZ Sint-Jan AV, Biosense Webster, Inc., Trium Clinical Consulting
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Feb 2021 (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.
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope (NMS).
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Two-third of the patients will be randomized to the active arm and one-third to the control arm (sham).
The study procedure is described in the 'detailed description' and 'intervention description'.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If syncope-free survival (primary endpoint) is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
Detailed description
The efficacy of therapeutic strategies mentioned in the guidelines for patients with neurally mediated syncope (NMS) is limited. The first clinical study on cardiac denervation in humans was published in 2005. Derived from this first method, different approaches to cardioneuroablation (CNA) to treat NMS have been published. Such ablations are complex, bi-atrial, and extensive. Cardio-neuromodulation (CardNM) is a less extensive and right-sided approach to CNA, based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus. Evidence from a single-center, non-randomized, unblinded trial showed that CardNM was associated with a reduction in syncope burden exceeding 90%.
This third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope.
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Two-thirds of the patients will be randomized to the active arm and one-third to the control arm (sham).
In all patients, the endocardial site to potentially target during ablation will be annotated before the procedure by a target line (TL) on a computed tomographic image of the heart imported into the CARTO system (Biosense Webster, Diamond Bar, CA), as detailed in the 'intervention description'.
The study procedure will be performed under general anesthesia according to a standardized protocol. In all patients, a diagnostic electrophysiology study (EPS) and electroanatomical mapping of the right atrium and the surrounding veins will be performed first. This image will be merged with the CT image and the TL will be visible. Randomization will be performed electronically at this stage of the procedure.
In patients assigned to the active arm, the TL will be targeted by ablation as detailed in the intervention description'.
The ablation procedure is considered complete when one of the following conditions is fulfilled:
- 10 radiofrequency applications have been delivered;
- After 5 radiofrequency applications, the P-P interval is <70% of the baseline procedural P-P interval and remains >550 ms 5 min after the last radiofrequency application;
- ≥5 radiofrequency applications have been delivered and the operator estimates that no additional P-P interval shortening will be obtained by additional radiofrequency applications;
- 3 radiofrequency applications have been delivered and the P-P interval is <550 ms after the last radiofrequency application and remains stable after 5 min of waiting.
In all patients, a pharmacological evaluation and new diagnostic EPS will be performed to further evaluate the sinus node and atrioventricular nodal intrinsic activity at the end of the procedure, either after the diagnostic part of the procedure in the sham group or after the ablation in the active arm.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires completed at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If the syncope-free survival, the primary endpoint of the study, is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Righ-sided ARGP ablation | Active comparator | Procedure: EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.two-thirds of the patients will be randomized to procedural arm A: a diagnostic evaluation followed by cardio-neuromodulation (CardNM) and a pharmacological evaluation |
| Placebo | Sham comparator | Procedure: EPS, electro-anatomical mapping, and pharmacological evaluation.one-third of the patients will be randomized to procedural arm B: a diagnostic evaluation followed by a pharmacological evaluation. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be in sinus rhythm and have ≥3 syncopes during the last 18 months* and a previous positive tilt table test (TTT) with a cardioinhibitory or mixed response (VASIS I, IIA or IIB classification).
- Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
Key exclusion criteria (16 listed)
- <14 years age
- Any unstable medical condition, life expectancy <12 months
- Inability to provide consent or undergo follow-up
- Syncope due to a non-cardiac disease or due to an advanced neuropathy
- Moderate to severe valvular or subvalvular aortic stenosis or mitral stenosis
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 |
|---|---|---|
| EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. Sequential ablations will be delivered along theTL until the procedure endpoint is reached. Pharmacological evaluation. | Procedure or surgery | Righ-sided ARGP ablation |
| EPS, electro-anatomical mapping, and pharmacological evaluation.Also: EPS, electro-anatomical mapping, no ablation, and pharmacological evaluation.EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. No ablation is performed (sham). Pharmacological evaluation. | Procedure or surgery | Placebo |
Primary outcome
Syncope free survival
Time frame: From date of randomization until the date of first syncope recurrence, assessed up to 12-month follow-up.
The primary efficacy endpoint is the number of days elapsed from study procedure to first syncope recurrence or to study close-out.
4 secondary outcomes
Syncope burden
Time frame: 1-, 3-, 6- and 12-month follow-up.
Number of beats with prespecified P-P intervals
Time frame: 1-, 3- and 6-month follow-up.
Heart rate variability
Time frame: 1-, 3- and 6-month follow-up.
Quality of life scale based on the questionnaire 'Impact of Syncope on Quality of Life (ISQL)
Time frame: 1-, 3-, 6- and 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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.
Philippe Debruyne, MD principal investigator
Imeldaziekenhuis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation. and EPS, electro-anatomical mapping, and pharmacological evaluation. in people with Syncope, Neurogenic and Syncope, run by Imelda Hospital, Bonheiden at 3 sites in Belgium.
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 16 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Debruyne, MD (0032478229896, philippe.debruyne@skynet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syncope free survival (time frame: From date of randomization until the date of first syncope recurrence, assessed up to 12-month follow-up.). 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 24 Apr 2025.