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Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope

RecruitingNAAges 14 Years - anyAllImelda Hospital, Bonheiden
NCT04755101 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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
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What it tests

  • EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.
  • EPS, electro-anatomical mapping, and pharmacological evaluation.
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Where

3 sites
Imeldaziekenhuis
Bonheiden, Belgium
Algemeen Ziekenhuis Sint Jan
Bruges, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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