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Ventricular Fibrillation
+1

Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.

Sponsored by SMART Clinical Products BV

About this trial

Last updated 4 years ago

Study ID

iD-System

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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
No

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

Locations

Location

Status