Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope

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.

Conditions

• Syncope, Neurogenic
• Syncope

Interventions

PROCEDURE

EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.

EPS 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.

PROCEDURE

EPS, electro-anatomical mapping, and pharmacological evaluation.

EPS 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• AZ Sint-Jan AV

  collaborator OTHER

• Biosense Webster, Inc.

  collaborator INDUSTRY

• Trium Clinical Consulting

  collaborator INDUSTRY

• Imelda Hospital, Bonheiden

  lead OTHER

Principal Investigators

• Philippe Debruyne, MD · Imeldaziekenhuis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-24

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Belgium

Study Locations