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NCT04755101: CardNMH3
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
NA trial testing EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation. in Syncope, Neurogenic in 110 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Imelda Hospital, Bonheiden |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 24 March 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 3 locations across Belgium |
Drugs / interventions tested
- EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.
- EPS, electro-anatomical mapping, and pharmacological evaluation.
Conditions studied
- Syncope, Neurogenic — all drugs for Syncope, Neurogenic →
- Syncope — all drugs for Syncope →
Sponsor
Imelda Hospital, Bonheiden
Who can join
14 and older, any sex, with Syncope, Neurogenic or Syncope. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical controversy: methodology and indications of cardioneuroablation for reflex syncope.
Brignole M, Aksu T, Calò L, Debruyne P, et al · · 2023 · cited 48× · PMID 37021351 · DOI 10.1093/europace/euad033 -
Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart R
Aksu T, Brignole M, Calo L, Debruyne P, et al · · 2024 · cited 45× · PMID 39082698 · DOI 10.1093/europace/euae206 -
Cardioneuroablation: Where are we at?
Pachon JC, Pachon EI, Aksu T, Gopinathannair R, et al · · 2023 · cited 27× · PMID 37361615 · DOI 10.1016/j.hroo.2023.02.007 -
Cardioneuroablation for Cardioinhibitory Vasovagal Syncope: Rationale, Approaches, and Its Role in Long-Term Management.
Aksu T, Chung MK. · · 2024 · cited 4× · PMID 38707611 · DOI 10.1007/s12170-024-00736-7 -
Cardioneuroablation: A Comprehensive Review
Conti S, Porto A, Zappulla P, Sgarito G. · · 2026 -
Cardioneuroablation for Asystolic Reflex Syncope: How to Identify the Best Candidate and How to Predict Success.
Kulakowski P. · · 2025 · PMID 40918691 · DOI 10.15420/aer.2025.25
Verify or expand the search:
- PubMed search for NCT04755101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04755101 (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: 24 April 2025
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/NCT04755101.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing