Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope (NCT04755101) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
Belgium110 participantsStarted 2021-03-24
Plain-language 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 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.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* \<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%
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Syncope free survival
Timeframe: From date of randomization until the date of first syncope recurrence, assessed up to 12-month follow-up.