Acute Feasibility Investigation of a New S-ICD Electrode

NCT03802110 | Completed Results DMC FDA Device

• 1 other identifier: C2081
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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

Conditions

Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules

  Acute- During the implant procedure- up to 1 hour

Study Arms (1)

Single Arm

EXPERIMENTAL

Defibrillation threshold (DFT) testing Arm

Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.

Interventions

commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter. DEVICE

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

Also known as: The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest

Single Arm

Eligibility Criteria

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

You may qualify if:

• Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
• Passing S-ICD screening ECG performed per applicable user's manual.
• Subject is willing and capable of providing informed consent specific to local and national laws.
• Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.

You may not qualify if:

• 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.
• Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
• Subject has NYHA Class IV or unstable Class III heart failure.
• Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
• Subject is morbidly obese, defined as BMI ≥ 35.
• Subject has an active infection or has been treated for infection within the past 30 days.
• Subject that, in the opinion of the investigator, has an increased risk of infection.
• Subject is currently requiring/receiving dialysis.
• Subject has insulin-dependent diabetes.
• Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
• Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
• Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
• Subject is currently on an active heart transplant list.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus MC - University Medical Center Rotterdam

Rotterdam, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Ventricular Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Limitations and Caveats

The study excluded certain patients believed to have the potential for higher DFTs and greater risk for AE.2 subjects were not tested with either two-electrode configuration due to requirement that VF must first be successfully converted in the Single configuration with 65 J. The sample size was small,subjects may have characteristics that do not perfectly match S-ICD recipients. In this cohort of patients from the Netherlands, age younger and BMI somewhat lower than what might occur in the US

Results Point of Contact

• Title: Stephen J. Hahn, PhD
• Organization: Boston Scientific Cardiac Rhythm Management

stephen.hahn@bsci.com

1-800-227-3422

Study Officials

• Reinoud Knops

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: January 14, 2019
• Study Start: November 29, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 9, 2024
• Results First Posted: May 9, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)