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NCT04372654

Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients

Completed NA Last updated 1 March 2021
What this trial tests

NA trial testing Electroducer Sleeve in Coronary Disease in 60 participants. Completed in 22 February 2021.

Timeline
28 July 2020
Primary endpoint
25 January 2021
22 February 2021

Quick facts

Lead sponsorElectroducer
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment60
Start date28 July 2020
Primary completion25 January 2021
Estimated completion22 February 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

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):

  1. 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

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