N/A
Completed N=100
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
ventricular fibrillation · Ventricular Tachycardia
Source: ClinicalTrials.gov NCT04011631 ↗
Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Feb 2021
Primary outcomePrimary: Number of Patients With Skin Symptoms — 0 Participants
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, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Skin Symptoms |
— | — |
| PRIMARY Number of Patients With Increased Troponin-t Level Classified as Adverse Event |
5 | — |
| PRIMARY Number of Patients Where the iD-System TM Fails |
1 | — |
| PRIMARY Ease of Use of the iD-System as Assessed Via Investigator Questionnaire |
0; 0; 91; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04011631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.