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Tests treatment safety and results for Syncope, Neurogenic
Official title Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
ClinicalTrials.gov ID: NCT04755101
What this study is testing
- What it's testing
- 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-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope (NMS). The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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...
- Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
You likely can't join if
- \<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%
See the full eligibility 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...
- Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
- \<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
The study team makes the final eligibility decision.
Where it's taking place
- Bonheiden, Belgium
- Bruges, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonheiden, Belgium; Bruges, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.