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

NCT04011631 | Completed Results DMC

• 1 other identifier: iD-System
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Ventricular Fibrillation; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (4)

• Number of Patients With Skin Symptoms

  Safety of the iD-system will be evaluated to assess if there are skin symptoms to the electrode by confirming if irritation is visible on the back of the patient after removal of the iD elektrode or not. For the more subjects the irritation will be visible, the worse will be the safety of the iD-elektrode.

  During intra-thoracic procedure

• Number of Patients With Increased Troponin-t Level Classified as Adverse Event

  Safety of the iD-system will be evaluated via troponine measurement to assess myocardial injury. Troponine will be measured at 4, 8, 16, 24 and 36 hours post-surgery and will be reported in ng/L. A significant increase of the troponine value during these different time points indicates myocardial injury. The investigator will evaluate every case to assess if it is an Adverse Event or not.

  During intra-thoracic procedure till 36 hours post surgery

• Number of Patients Where the iD-System TM Fails

  Efficacy of the the iD-System will be evaluated to assess a successful restoration of the sinus rythm by counting the number of failed attempts to defibrillate which were attributable to device malfunction. This will be captured by a questionnaire, to be completed by the investigator after the surgery. A maximum of 4 shocks can be applied. If the normal arterial hearth rhythm cannot be restored after 4 shocks with the iD-System, conversion to the conventional system occurs.

  During intra-thoracic procedure

• Ease of Use of the iD-System as Assessed Via Investigator Questionnaire

  Ease of use of the iD-System will be evaluated by a questionnaire, to be completed after the procedure. The following items will be assessed: * adherence of the iD-Electrode to the patient's back * positioning of the iD-Padde for maximal contact with the heart * working length of the following cables: iD-Electrode,iD-Paddle and the iD-SMART Cable The questionnaire will consist of 16 questions, each addressing a specific topic of the ease of use, to be scored by the investigator from 1 to 5. 1= very poor, 2= poor, 3= neutral, 4= sufficient, 5= excellent The higher the total score, the better the outcome of the 'ease of use' evaluation.

  During intra-thoracic procedure

Study Arms (1)

Patients with cardiac surgery

EXPERIMENTAL

All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.

Procedure: Internal defibrillation during cardiac surgery, using the iD-system

Interventions

Internal defibrillation during cardiac surgery, using the iD-system PROCEDURE

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.

Patients with cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SMART Clinical Products BV: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, B3600, Belgium

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Ellie Coumans
• Organization: SMART Clinical Products

e.coumans@smartclinicalproducts.com

+31 (0)6 53 82 70 16

Study Officials

• M. Beran, Dr.

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants / patients treated in the study are blinded for the sponsor.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective interventional study with medical device.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 8, 2019
• Study Start: September 3, 2018
• Primary Completion: May 6, 2019
• Study Completion: July 31, 2019
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)