Brief summary

The objective of this trial is to assess the peri procedural safety of ELECTRODUCER SLEEVE device used for temporary cardiac pacing during percutaneous cardiovascular interventions, by radial and femoral routes of access.

This is a pilot, prospective, multi-center, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.

Primary endpoints

The device safety is assessed through the occurrence of bleeding complications at the access site where the ELECTRODUCER SLEEVE was used, including: Hematoma formation (EASY Classification) and Access-site Bleeding (BARC classification).

CERC Services

Project Management

Data Management

Contracts Management

Monitoring & site follow up

Safety and SAE reporting

Countries 

1 country (France)

Centers number

3 centers

💡 Read more about the ELECTRODUCER device 👉https://www.electroducer.io/