Last reviewed · How we verify

NCT02954666: CardNMH2

Second Study on Cardio-neuromodulation in Humans

Completed NA Last updated 20 January 2021
What this trial tests

NA trial testing radio-frequency ablation in Cardiac Disease in 50 participants. Completed in 11 May 2020.

Timeline
10 December 2016
Primary endpoint
1 April 2020
11 May 2020

Quick facts

Lead sponsorImelda Hospital, Bonheiden
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date10 December 2016
Primary completion1 April 2020
Estimated completion11 May 2020
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Imelda Hospital, Bonheiden

Who can join

14 and older, any sex, with Cardiac Disease or Syncope. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Durable Physiological Changes and Decreased Syncope Burden 12 Months After Unifocal Right-Sided Ablation Under Computed Tomographic Guidance in Patients With Neurally Mediated Syncope or Functional Sinus Node Dysfunction.
    Debruyne P, Rossenbacker T, Janssens L, Collienne C, et al · · 2021 · cited 44× · PMID 33999698 · DOI 10.1161/circep.120.009747

Verify or expand the search:

Other recruiting trials for Cardiac Disease

Currently open trials in the same condition.

Other Imelda Hospital, Bonheiden trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02954666.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing