Last reviewed · How we verify
NCT04372654
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
NA trial testing Electroducer Sleeve in Coronary Disease in 60 participants. Completed in 22 February 2021.
25 January 2021
Quick facts
| Lead sponsor | Electroducer |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 28 July 2020 |
| Primary completion | 25 January 2021 |
| Estimated completion | 22 February 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Electroducer Sleeve
Conditions studied
- Coronary Disease — all drugs for Coronary Disease →
- Valve Heart Disease — all drugs for Valve Heart Disease →
- Pacemaker DDD — all drugs for Pacemaker DDD →
Sponsor
Electroducer
Who can join
Adults 18 to 99, any sex, with Coronary Disease or Valve Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During percutaneous cardiovascular intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter. In order to reduce the complexity of the procedure, a new stimulation strategy has been developed: the "Direct Wire Pacing technique".In this approach, the cardiac stimulation is provided via the guidewire connected to an external pacemaker. Previous study demonstrated the superiority of the new technique compared to the former. However this technique is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used. The "Direct Wire Pacing technique" is simplified, secured and more reproducible.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.
Wintzer-Wehekind J, Lefèvre T, Benamer H, Monsegu J, et al · · 2023 · cited 2× · PMID 36484703 · DOI 10.4244/eij-d-22-00662
Verify or expand the search:
- PubMed search for NCT04372654
- 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 NCT04372654 (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 Electroducer
- Last refreshed: 1 March 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/NCT04372654.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing