Trial Outcomes & Findings for Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System (NCT NCT00853645)

NCT ID: NCT00853645

Last Updated: 2021-07-06

Results Overview

Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-07-06

Participant Flow

Participant milestones

Measure	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System Single-arm with 6 patients implanted with an S-ICD System
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Baseline characteristics by cohort

Measure	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System n=6 Participants Single-arm with 6 patients implanted with an S-ICD System
Age, Continuous	60.24 Years STANDARD_DEVIATION 11.42 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment New Zealand	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.

Outcome measures

Measure	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System n=6 Participants Single-arm with 6 patients implanted with an S-ICD System
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion	6 Participants

Adverse Events

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System n=6 participants at risk Single-arm with 6 patients implanted with an Subcutaneous implantable cardioverter defibrillator (S-ICD) System
Cardiac disorders Severe acute coronary syndrome.	16.7% 1/6 • Number of events 1 • 1 month

Other adverse events

Measure	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System n=6 participants at risk Single-arm with 6 patients implanted with an Subcutaneous implantable cardioverter defibrillator (S-ICD) System
Product Issues Pulse generator rotation	50.0% 3/6 • Number of events 3 • 1 month
Product Issues Inappropriate paced beats post shock	16.7% 1/6 • Number of events 1 • 1 month
Surgical and medical procedures Electrode removed and retunneled at implant	16.7% 1/6 • Number of events 1 • 1 month

Additional Information

Gena Kantor, MPH

Boston Scientific

Phone: 1-800-227-3422

Email: gena.kantor@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place