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.

Detailed Description

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD, EMBLEM®, Boston Scientific Corp) delivers 80 J shocks from an 8 cm left-parasternal coil (LPC) to a 59 cc left lateral pulse generator (PG). A system that defibrillates with lower energy could significantly reduce PG size. Computer modeling and animal studies suggest a 2nd shock coil either parallel (P) to LPC or transverse (T) from xiphoid to PG pocket would significantly reduce shock impedance and defibrillation threshold (DFT).

Objective: Acutely test defibrillation efficacy of P and T configurations in patients receiving an S-ICD.

Methods: Testing was performed in patients receiving a conventional S-ICD system (C) for standard indications. Patients at risk for conversion failure, stroke or infection were excluded. A 65 J success with the conventional S-ICD was required prior to investigational testing. A second electrode was temporarily inserted from the xiphoid incision using the same introducer and sheath tools and connected to the PG with an investigational Y-adapter (Model 3598, Boston Scientific). Phase 1 (n=11) tested only P at a starting energy of 50 J with subsequent tests at 65 or 30 J then 40 or 20 J depending upon outcome. Phase 2 (n=21) tested both P and T in random order, starting at 30 J then either 40 or 20 J.

• 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

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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
Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules	The primary objective of this acute feasibility study is to measure the DFT of the new shock electrode configuration with an S-ICD system. The unit of measure will be in Joules. Ventricular Fibrillation (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- up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules	The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. 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- up to 1 hour

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): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: October 1, 2023

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