Status:
RECRUITING
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
Lead Sponsor:
Imelda Hospital, Bonheiden
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
AZ Sint-Jan AV
Conditions:
Syncope, Neurogenic
Syncope
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-...
Detailed Description
The efficacy of therapeutic strategies mentioned in the guidelines for patients with neurally mediated syncope (NMS) is limited. The first clinical study on cardiac denervation in humans was published...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04755101
Start Date
March 24 2021
End Date
December 31 2026
Last Update
April 24 2025
Active Locations (3)
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1
Imeldaziekenhuis
Bonheiden, Belgium, 2820
2
Algemeen Ziekenhuis Sint Jan
Bruges, Belgium, 8000
3
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000