Actively Recruiting
Cardio-Neuromodulation in Humans, 3rd Study: CT-Guided Right-Sided Ablation for Neurally Mediated Syncope
Led by Imelda Hospital, Bonheiden · Updated on 2025-04-24
110
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Imelda Hospital, Bonheiden
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrent syncope in patients with neurally mediated syncope (NMS). This multicenter, double-blind, randomized trial compares this procedure against a sham control to assess its safety and effectiveness in reducing syncope episodes and improving quality of life. The study builds on previous research showing promise for less extensive cardioneuroablation methods like Cardio-neuromodulation (CardNM). Participants will be randomly assigned with two-thirds receiving the active treatment involving CT-guided ablation of the anterior right-ganglionated plexus and one-third receiving a sham procedure without ablation. Both groups undergo diagnostic electrophysiology study (EPS) and electroanatomical mapping merged with CT images. The ablation procedure under general anesthesia targets a specific heart area until predefined endpoints are reached. Pharmacological evaluation and new diagnostic EPS are done after the procedure in both groups. Participants will complete questionnaires about syncope burden, occurrence, and quality of life at baseline and at 1, 3, 6, and 12 months. Heart rhythm monitoring will be done at baseline and during follow-up visits. Two substudies will assess blood pressure and sinus node function through 24-hour blood pressure monitoring and bicycle exercise tests. The study aims for full follow-up of 110 patients but may stop early if results are significantly different or safety concerns arise. The primary outcome is syncope-free survival over 12 months.
CONDITIONS
Brief Title
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be in sinus rhythm
- At least 3 syncope episodes in the last 18 months (excluding those during tilt table tests)
- Previous positive tilt table test with cardioinhibitory or mixed response (VASIS I, IIA, or IIB)
- Preserved cholinergic sinus node reserve defined as at least 20% sinus heart rate increase during atropine test
You will not qualify if you...
- Age under 14 years
- Unstable medical condition with life expectancy under 12 months
- Inability to consent or participate in follow-up
- Syncope caused by non-cardiac disease or advanced neuropathy
- Moderate to severe aortic or mitral valve stenosis
- Heart failure or left ventricular ejection fraction below 45%
- Current pregnancy
- Use of chronotropic negative medications unless mandatory
- Amiodarone use in the 2 months before enrollment
- Certain heart conduction abnormalities (alternating bundle branch blocks, prolonged HV interval, bifascicular block, prolonged PR interval)
- Presence of pacemaker or implantable cardioverter defibrillator
- Permanent or recent atrial fibrillation
- Known channelopathy
- Tilt table test with VASIS III response or VASIS II with AV-Block
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo assessments to confirm eligibility including medical history and diagnostic tests.
Duration - Single procedure day
Participants undergo a diagnostic electrophysiology study and electro-anatomical mapping under general anesthesia. Those randomized to the active arm receive a CT-guided right-sided ablation targeting the anterior ganglionated plexus, while those in the control arm receive a sham procedure. Pharmacological evaluation follows the procedure in all participants.
1 in-person procedure visit under general anesthesia
Duration - 12 months post-procedure
Participants complete questionnaires and undergo 24-hour rhythm monitoring at 1, 3, 6, and 12 months to assess syncope occurrence, syncope burden, heart rate, and quality of life. Additional monitoring such as blood pressure and exercise tests may occur depending on substudy participation.
In-person visits at 1, 3, 6, and 12 months; 24-hour monitoring at 1, 3, and 6 months
Trial Site Locations
Total: 3 locations
1
Imeldaziekenhuis
Bonheiden, Belgium, 2820
Actively Recruiting
2
Algemeen Ziekenhuis Sint Jan
Bruges, Belgium, 8000
Not Yet Recruiting
3
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
Research Team
P
Philippe Debruyne, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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