NCT03802110

Acute Feasibility Investigation of a New S-ICD Electrode

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-29
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2019-01-14
• Last updated: 2024-05-09
• Results posted: 2024-05-09

Locations

4 sites across 1 country: Netherlands

Regulatory

• FDA-regulated device study