Status:
COMPLETED
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
Lead Sponsor:
SMART Clinical Products BV
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Conditions:
Ventricular Fibrillation
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure...
Detailed Description
The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure...
Eligibility Criteria
Inclusion
- All races and ethnicity (\>18 years)
- Written informed consent form (ICF) has to be obtained from the patient.
- Elective surgery: cardiac surgery on pump (CPB)
- Coronary artery bypass surgery
- Heart valve repair and/or replacement
- Mini sternotomy
- Median sternotomy
- Redo surgery
Exclusion
- Patients without cardiopulmonary bypass (referred to as heart-lung machine or pump)
- Emergency surgery without a sufficient amount of time to explain and ask for ICF
Key Trial Info
Start Date :
September 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04011631
Start Date
September 3 2018
End Date
July 31 2019
Last Update
February 2 2021
Active Locations (1)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium, B3600