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

Launched by IMELDA HOSPITAL, BONHEIDEN · Feb 11, 2021

Keywords

ClinConnect Summary

This clinical trial, called the CardNMH3 study, is looking at a new treatment option for patients who experience frequent fainting spells, known as neurally mediated syncope (NMS). The researchers want to find out if a procedure that uses imaging technology (CT-guided right-sided ablation of the anterior ganglionated plexus) can help reduce the number of fainting episodes. In this study, two-thirds of participants will receive the actual treatment, while one-third will receive a placebo, which is a treatment that looks the same but does not have any active ingredients. The goal is to see if the treatment safely lowers the risk of fainting again.

To be eligible for this trial, participants must be 14 years or older and have experienced at least three fainting episodes in the last 18 months, along with a specific positive test result that shows a response related to their condition. During the study, participants will fill out questionnaires about their fainting episodes and quality of life at various times over the next year. They will also undergo heart monitoring to assess how the treatment affects their heart rate and blood pressure. It’s important to note that certain health conditions and medications may exclude individuals from participating in the trial. If the treatment proves to be effective early on, the trial may stop enrolling new participants.

Gender

ALL

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