NCT03802110: ASE

Acute Feasibility Investigation of a New S-ICD Electrode

Completed NA Results posted Last updated 9 May 2024

What this trial tests

NA trial testing commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter. in Ventricular Fibrillation in 42 participants. Completed in 1 April 2022.

Timeline

29 November 2018

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	42
Start date	29 November 2018
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	4 locations across Netherlands

Drugs / interventions tested

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

Conditions studied

• Ventricular Fibrillation — all drugs for Ventricular Fibrillation →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Ventricular Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules Primary · Acute- During the implant procedure- up to 1 hour

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

Group	Value	95% CI
Parallel Shock Configuration	27.0	± 8.8
Transverse Shock Configuration	31.5	± 9.3

Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules Secondary · Acute- During the implant procedure- up to 1 hour

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

Group	Value	95% CI
Parallel Shock Configuration	32
Transverse Shock Configuration	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Reporting of events occurred during the period the subject was considered to be enrolled in the study: from implant up to 3 months after implant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm

Serious: 1/42 (2%)

Deaths: 0/42

Serious adverse events (1 terms)

Reaction	System	Single Arm
Ventricular Fibrilation	Cardiac disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Single Arm
Inadvertent Arrhythmia	Injury, poisoning and procedural complications	—
Inappropriate Tachy Therapy Noise (Non-Cardiac)	Product Issues	—
Hematoma-PG pocket (<or+ 30d post implant)	Injury, poisoning and procedural complications	—
Adverse Reaction-Allergic reaction	General disorders	—
Patient condition non-cardiovascular other	General disorders	—
Post surgical wound discomfort PG site (<30d post implant)	Injury, poisoning and procedural complications	—
Incisional/superficial infection(<30 d post implant without explant)	Injury, poisoning and procedural complications	—
Hemodynamic Instability	Injury, poisoning and procedural complications	—
S-ICD System Procedure Related - OTHER	Injury, poisoning and procedural complications	—
Incisional/superficial infection(>30d post implant)	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Ventricular Fibrilation.

Data from ClinicalTrials.gov NCT03802110 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiac Electronic Devices: Future Directions and Challenges.
   Kotalczyk A, Kalarus Z, Wright DJ, Boriani G, et al · · 2020 · cited 18× · PMID 33061681 · DOI 10.2147/mder.s245625