Acute Feasibility Investigation of a New S-ICD Electrode (ASE)

Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies

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

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation
• Intervention / Treatment: Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus MC - University Medical Center Rotterdam
  • Zwolle, Netherlands
    • ISALA Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules	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	Acute- During the implant procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion succes of the new electrode configuration	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	Acute- During the implant procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Reinoud Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2018
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Ventricular Fibrillation
• Other Study ID Numbers: C2081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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