Status:
COMPLETED
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
Lead Sponsor:
Electroducer
Conditions:
Coronary Disease
Valve Heart Disease
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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...
Detailed Description
During percutaneous cardiovascular interventions such as Transcatheter Heart Valve or coronary intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a ...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old
- Patients with a percutaneous cardiovascular intervention indication, requiring temporary cardiac stimulation
- Procedure carried out with a 6Fr TERUMO introducer ≥ 65 mm
- Procedure performed by femoral or radial routes
- Patients able to understand and provide informed consent
- Patients able to perform the planned follow-up visit one month after the procedure.
Exclusion
- Patients requiring a definitive PM
- Pregnant or breastfeeding woman
- Patiens under judicial protection, tutorship or curatorship
- Negative Allen test or absence of radial pulse in the artery or vein used for intervention
- Patient participating in another interventional clinical trial.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04372654
Start Date
July 28 2020
End Date
February 22 2021
Last Update
March 1 2021
Active Locations (1)
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1
GHMG
Grenoble, France