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NCT02954666: CardNMH2
Second Study on Cardio-neuromodulation in Humans
NA trial testing radio-frequency ablation in Cardiac Disease in 50 participants. Completed in 11 May 2020.
1 April 2020
Quick facts
| Lead sponsor | Imelda Hospital, Bonheiden |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 10 December 2016 |
| Primary completion | 1 April 2020 |
| Estimated completion | 11 May 2020 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- radio-frequency ablation
Conditions studied
- Cardiac Disease — all drugs for Cardiac Disease →
- Syncope — all drugs for Syncope →
- Syncope, Vasovagal — all drugs for Syncope, Vasovagal →
- Sick Sinus Syndrome — all drugs for Sick Sinus Syndrome →
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):
-
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:
- PubMed search for NCT02954666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05877755 — Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging · NA · recruiting
Other Imelda Hospital, Bonheiden trials
Trials by the same sponsor.
- NCT05246813 — Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP) · recruiting
- NCT04755101 — Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope · NA · recruiting
- NCT04770597 — Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital · NA · completed
- NCT02630329 — Notes Adnexectomy for Benign Pathology Compared to Laparoscopic Excision · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02954666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Imelda Hospital, Bonheiden
- Last refreshed: 20 January 2021
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