Right-sided ablation to prevent fainting episodes

Cardio-Neuromodulation in Humans, 3th Study

This study is testing if a new procedure that targets a specific area in the heart can help people with neurally mediated syncope (fainting) have fewer fainting episodes compared to those who receive a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Imelda Hospital, Bonheiden (Academic / other)
• Locations: 3 sites (Bonheiden and 2 other locations)
• Trial ID: NCT04755101 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with a history of recurrent syncope and a positive tilt table test indicating a cardioinhibitory or mixed response.

Not a fit: Patients with syncope due to non-cardiac diseases or those with severe heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the frequency of fainting episodes in patients with neurally mediated syncope.

How similar studies have performed: Previous studies on cardioneuroablation have shown promising results, indicating that this approach may be effective, although this specific method is relatively novel.

Eligibility criteria

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 this trial is running

Bonheiden and 2 other locations

• Imeldaziekenhuis — Bonheiden, Belgium (Recruiting)
• Algemeen Ziekenhuis Sint Jan — Bruges, Belgium (Not_yet_recruiting)
• Universitair Ziekenhuis Gasthuisberg — Leuven, Belgium (Recruiting)

Study contacts

• Principal investigator: Philippe Debruyne, MD — Imeldaziekenhuis
• Study coordinator: Philippe Debruyne, MD

Conditions Syncope, Neurogenic; Syncope; cardioneuroablation; cardio-neuromodulation; ganglionated plexi; right-anterior ganglionated plexus; ablation