Trial Outcomes & Findings for Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation (NCT NCT01117792)

NCT ID: NCT01117792

Last Updated: 2021-07-02

Results Overview

The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: Testing done during the implant procedure
• Results posted on: 2021-07-02

Participant Flow

Participant milestones

Measure	S-ICD System Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
Overall Study STARTED	55
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	S-ICD System Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
Overall Study Death	1
Overall Study Adverse Event	3

Baseline Characteristics

Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Baseline characteristics by cohort

Measure	S-ICD System n=55 Participants Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
Age, Continuous	56.1 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	34 Participants n=5 Participants
Race/Ethnicity, Customized European	9 Participants n=5 Participants
Race/Ethnicity, Customized New Zealander, European	8 Participants n=5 Participants
Race/Ethnicity, Customized Maori	2 Participants n=5 Participants
Race/Ethnicity, Customized Indian	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment New Zealand	21 participants n=5 Participants
Region of Enrollment Netherlands	21 participants n=5 Participants
Region of Enrollment Italy	5 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Testing done during the implant procedure

Population: Investigator induce sustained ventricular fibrillation conversion efficacy. Two of the 55 subjects implanted did not induce sustained ventricular fibrillation leaving 53 evaluable subjects.

The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.

Outcome measures

Measure	S-ICD System n=53 Participants Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
Conversion of Induced Ventricular Fibrillation	52 Participants

Adverse Events

S-ICD System

Serious events: 17 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	S-ICD System n=55 participants at risk Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
General disorders Other - Adverse Event Terms Unknown	30.9% 17/55 • Number of events 22

Other adverse events

Measure	S-ICD System n=55 participants at risk Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
General disorders Other - Adverse Event Terms Unknown	7.3% 4/55 • Number of events 4

Additional Information

Tom Stoltz, Clinical Trial Manager

Boston Scientific

Phone: 1-800-227-3422

Email: thomas.stoltz@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER