Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope (CardNMH3)
Syncope, Neurogenic, Syncope
About this trial
This is an interventional treatment trial for Syncope, Neurogenic focused on measuring cardioneuroablation, cardio-neuromodulation, ganglionated plexi, right-anterior ganglionated plexus, ablation
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
Sites / Locations
- ImeldaziekenhuisRecruiting
- Algemeen Ziekenhuis Sint Jan
- Universitair Ziekenhuis GasthuisbergRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Righ-sided ARGP ablation
Placebo
two-thirds of the patients will be randomized to procedural arm A: a diagnostic evaluation followed by cardio-neuromodulation (CardNM) and a pharmacological evaluation
one-third of the patients will be randomized to procedural arm B: a diagnostic evaluation followed by a pharmacological evaluation.