Trial Outcomes & Findings for Acute Feasibility Investigation of a New S-ICD Electrode (NCT NCT03802110)

Last Updated: 2024-05-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

Acute- During the implant procedure- up to 1 hour

Results posted on

2024-05-09

Participant Flow

Subjects who were scheduled to receive an subcutaneous implantable cardioverter defibrillator (S-ICD), and fulfilled the inclusion and exclusion criteria, could be approached for enrollment and consent within 30 days of their scheduled implant.

Participant milestones

Participant milestones
Measure	Acute Test Subjects who signed the Informed Consent Form (ICF) and were considered enrolled.
Overall Study STARTED	42
Overall Study Started Testing	35
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Test n=35 Participants Subjects receiving a commercial S-ICD system for per manufacturer indications and medical society guidelines
Age, Continuous	51 years STANDARD_DEVIATION 17 • n=35 Participants
Sex: Female, Male Female	7 Participants n=35 Participants
Sex: Female, Male Male	28 Participants n=35 Participants
Region of Enrollment Netherlands	35 participants n=35 Participants
Left Ventricular Ejection Fraction	40 percent STANDARD_DEVIATION 15 • n=35 Participants

PRIMARY outcome

Timeframe: Acute- During the implant procedure- up to 1 hour

Population: transverse testing was added in phase 2, so fewer subjects tested. Only subjects completing testing were analyzed

Outcome measures

Outcome measures
Measure	Parallel Shock Configuration n=33 Participants Acute VF conversion test: shock delivered from two left parasternal coil electrodes inserted in parallel to a left lateral PG	Transverse Shock Configuration n=20 Participants Acute VF conversion test: shock delivered from left parasternal coil Plus transverse coil (xiphoid towards PG) to left lateral PG
Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules	27.0 Joules Standard Deviation 8.8	31.5 Joules Standard Deviation 9.3

SECONDARY outcome

Timeframe: Acute- During the implant procedure- up to 1 hour

Population: Transverse was added in Phase 2 so fewer subjects tested.

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

Outcome measures

Outcome measures
Measure	Parallel Shock Configuration n=33 Participants Acute VF conversion test: shock delivered from two left parasternal coil electrodes inserted in parallel to a left lateral PG	Transverse Shock Configuration n=20 Participants Acute VF conversion test: shock delivered from left parasternal coil Plus transverse coil (xiphoid towards PG) to left lateral PG
Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules	32 Participants	18 Participants

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=42 participants at risk Defibrillation threshold (DFT) testing Arm 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
Cardiac disorders Ventricular Fibrilation	2.4% 1/42 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Single Arm n=42 participants at risk Defibrillation threshold (DFT) testing Arm 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
General disorders Adverse Reaction-Allergic reaction	2.4% 1/42 • Number of events 1 • 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.
General disorders Patient condition non-cardiovascular other	2.4% 1/42 • Number of events 1 • 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.
Product Issues Inappropriate Tachy Therapy Noise (Non-Cardiac)	7.1% 3/42 • Number of events 3 • 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.
Injury, poisoning and procedural complications Post surgical wound discomfort PG site (<30d post implant)	2.4% 1/42 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incisional/superficial infection(<30 d post implant without explant)	2.4% 1/42 • Number of events 1 • 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.
Injury, poisoning and procedural complications Inadvertent Arrhythmia	9.5% 4/42 • Number of events 4 • 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.
Injury, poisoning and procedural complications Hematoma-PG pocket (<or+ 30d post implant)	4.8% 2/42 • Number of events 2 • 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.
Injury, poisoning and procedural complications Hemodynamic Instability	2.4% 1/42 • Number of events 1 • 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.
Injury, poisoning and procedural complications S-ICD System Procedure Related - OTHER	2.4% 1/42 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incisional/superficial infection(>30d post implant)	2.4% 1/42 • Number of events 1 • 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.

Additional Information

Stephen J. Hahn, PhD

Boston Scientific Cardiac Rhythm Management

Phone: 1-800-227-3422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60