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Second Study on Cardio-neuromodulation in Humans

NCT02954666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-20

No results posted yet for this study

Summary

Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more limited and specific approach of CNA, called cardio-neuromodulation (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an innovative anatomic strategy. The feasibility of CardNM has already been tested in our center in a limited first study in humans (CardNMH1), with a favorable outcome for the patients involved. The results of CardNMH1 have been submitted for publication. The purpose of this second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data in well-defined patient groups.

Conditions

  • Cardiac Disease
  • Syncope
  • Syncope, Vasovagal
  • Sick Sinus Syndrome

Interventions

DEVICE

radio-frequency ablation

Patients will undergo a tailored 'radio-frequency ablation' of the ARGP with the Smart Touch™ catheter or with the nMARQ™ catheter. Radiofrequency applications will be interrupted if no significant P-P interval shortening is observed after 30 seconds or if P-P interval is ≤ 550 ms during ablation. The ablation procedure is considered complete when one of the following conditions is fulfilled: P-P interval \< 70% baseline procedural P-P interval after 5minute of waiting time; P-P interval \< 600 ms after 5 minute of waiting time; 5 radiofrequency applications \> 30 seconds have been delivered with the nMARQ™ catheter or 10 applications with the Smart Touch catheter.

Sponsors & Collaborators

  • Imelda Hospital, Bonheiden

    lead OTHER

Principal Investigators

  • Philippe Debruyne, MD · Imeldahospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-10
Primary Completion
2020-04-01
Completion
2020-05-11

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954666 on ClinicalTrials.gov