Right-sided ablation to prevent fainting episodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized trial investigates the efficacy and safety of a CT-guided, right-sided ablation of the anterior ganglionated plexus in patients with neurally mediated syncope (NMS). The study aims to determine if this targeted ablation can reduce the recurrence of syncope episodes compared to a sham control group. Participants will undergo assessments of syncope burden and quality of life at multiple follow-up points, and the procedure involves electro-anatomical mapping and pharmacological evaluation. Two-thirds of the participants will receive the active treatment while one-third will receive a placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Imeldaziekenhuis
  Bonheiden, Belgium Recruiting
• Universitair Ziekenhuis Gasthuisberg
  Leuven, Belgium Recruiting
• Algemeen Ziekenhuis Sint Jan
  Bruges, Belgium Not yet recruiting

Study contacts

• Principal investigator: Philippe Debruyne, MD — Imeldaziekenhuis
• Study coordinator: Philippe Debruyne, MD
• Email: philippe.debruyne@skynet.be
• Phone: 0032478229896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.