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.
ID: NCT04372654
Sponsor
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
- CRF and Data management
- Contract management
- Site and Monitoring Management
- Safety reporting
Countries
France
Number of investigational sites
3
Number of patients
60
