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ASE: Acute Feasibility Investigation of a New S-ICD Electrode

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03802110
Collaborator
(none)
42
Enrollment
4
Locations
1
Arm
40
Actual Duration (Months)
10.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD

Condition or Disease Intervention/Treatment Phase
  • Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies
Actual Study Start Date :
Nov 29, 2018
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Defibrillation threshold (DFT) testing Arm

Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Other Names:
  • The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules [Acute- During the implant procedure]

      The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol

    Secondary Outcome Measures

    1. Conversion succes of the new electrode configuration [Acute- During the implant procedure]

      The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.

    2. Passing S-ICD screening ECG performed per applicable user's manual.

    3. Subject is willing and capable of providing informed consent specific to local and national laws.

    4. Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.

    Key Exclusion Criteria:

    1. Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode.

    2. Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.

    3. Subject has NYHA Class IV or unstable Class III heart failure.

    4. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.

    5. Subject is morbidly obese, defined as BMI ≥ 35.

    6. Subject has an active infection or has been treated for infection within the past 30 days.

    7. Subject that, in the opinion of the investigator, has an increased risk of infection.

    8. Subject is currently requiring/receiving dialysis.

    9. Subject has insulin-dependent diabetes.

    10. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.

    11. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.

    12. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.

    13. Subject is currently on an active heart transplant list.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academisch Medisch Centrum Amsterdam Netherlands
    2 St. Antonius Ziekenhuis Nieuwegein Netherlands
    3 Erasmus MC - University Medical Center Rotterdam Rotterdam Netherlands
    4 Isala Klinieken Zwolle Netherlands

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Reinoud Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT03802110
    Other Study ID Numbers:
    • C2081
    First Posted:
    Jan 14, 2019
    Last Update Posted:
    Apr 26, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Ventricular Fibrillation

    Study Results

    No Results Posted as of Apr 26, 2022