Trials / Completed
CompletedNCT04011631
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- SMART Clinical Products BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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, 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. In case ventricular fibrillation occurs and the iD-system is not effective to restore the sinus trythm, the conventional approach with use of the two paddels spoons will be performed immediately. the following will be assessed: * Ease of use of the device * Safety of the device * Efficacy of the device
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Internal defibrillation during cardiac surgery, using the iD-system | When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol. |
Timeline
- Start date
- 2018-09-03
- Primary completion
- 2019-05-06
- Completion
- 2019-07-31
- First posted
- 2019-07-08
- Last updated
- 2021-02-02
- Results posted
- 2021-02-02
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04011631. Inclusion in this directory is not an endorsement.