Cardio-Neuromodulation in Humans, 3th Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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-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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Imeldaziekenhuis
RECRUITING
Bonheiden
Algemeen Ziekenhuis Sint Jan
NOT_YET_RECRUITING
Bruges
Universitair Ziekenhuis Gasthuisberg
RECRUITING
Leuven
Contact Information
Primary
Philippe Debruyne, MD
philippe.debruyne@skynet.be
0032478229896
Time Frame
Start Date: 2021-03-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 110
Treatments
Active_comparator: Righ-sided ARGP ablation
two-thirds of the patients will be randomized to procedural arm A: a diagnostic evaluation followed by cardio-neuromodulation (CardNM) and a pharmacological evaluation
Sham_comparator: Placebo
one-third of the patients will be randomized to procedural arm B: a diagnostic evaluation followed by a pharmacological evaluation.
Sponsors
Collaborators: AZ Sint-Jan AV, Trium Clinical Consulting, Universitaire Ziekenhuizen KU Leuven, Biosense Webster, Inc.
Leads: Imelda Hospital, Bonheiden

This content was sourced from clinicaltrials.gov