Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorImelda Hospital, Bonheiden
About this trial
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.
Two-third of the patients will be randomized to the active arm and one-third to the control arm (sham).
The study procedure is described in the 'detailed description' and 'intervention description'.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If syncope-free survival (primary endpoint) is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
Disqualifiers
<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
Trial design
Design model
Parallel
Treatments tested in this trial
EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.
Procedure/SurgeryEPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. Sequential ablations will be delivered along theTL until the procedure endpoint is reached. Pharmacological evaluation.
EPS, electro-anatomical mapping, and pharmacological evaluation.
Procedure/SurgeryEPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. No ablation is performed (sham). Pharmacological evaluation.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Righ-sided ARGP ablationActive comparator 1 intervention
Group B: PlaceboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Syncope free survival
The primary efficacy endpoint is the number of days elapsed from study procedure to first syncope recurrence or to study close-out.
Time frame
From date of randomization until the date of first syncope recurrence, assessed up to 12-month follow-up.Secondary outcomes
1
Syncope burden
Corrected cumulative number of syncope episodes
Time frame
1-, 3-, 6- and 12-month follow-up.2
Number of beats with prespecified P-P intervals
Mean number of beats with prespecified P-P intervals over 24-h
Time frame
1-, 3- and 6-month follow-up.3
Heart rate variability
Standard deviation of the average NN (SDNN)
Time frame
1-, 3- and 6-month follow-up.4
Quality of life scale based on the questionnaire 'Impact of Syncope on Quality of Life (ISQL)
Comparison of scores; higher scores mean a better outcome.
Time frame
1-, 3-, 6- and 12-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imelda Hospital, Bonheiden
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
AZ Sint-Jan AV
Collaborator
Biosense Webster, Inc.
Collaborator
Trium Clinical Consulting
Collaborator
Source ClinicalTrials.gov