Acute Feasibility Investigation of a New S-ICD Electrode

NCT ID: NCT03802110

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2022-04-01

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

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.

Conditions

Ventricular Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single Arm

Defibrillation threshold (DFT) testing Arm

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reinoud Knops

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Academisch Medisch Centrum

Amsterdam, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus MC - University Medical Center Rotterdam

Rotterdam, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C2081

Identifier Type: -

Identifier Source: org_study_id