An interventional study of Subcutaneous Implantable Defibrillator (S-ICD) System in Ventricular Tachyarrhythmias, sponsored by Boston Scientific Corporation. Completed at 2 sites in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Device feasibility
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 6 is below the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single-arm with 6 patients implanted with an S-ICD System
Device: Subcutaneous Implantable Defibrillator (S-ICD) System
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
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.
Time frame: 30 days
| Milestone | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| Participants | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Number of Participants With a Successful Induced Ventricular Fibrillation Conversion | 6 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) |
| Event | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Severe acute coronary syndrome.Cardiac disorders | 1/6 |
| Event | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Pulse generator rotationProduct Issues | 3/6 |
| Inappropriate paced beats post shockProduct Issues | 1/6 |
| Electrode removed and retunneled at implantSurgical and medical procedures | 1/6 |
| Age, Continuous(Years) | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Mean | 60.24 ± 11.42 |
| Sex: Female, Male(Participants) | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| Female | 0 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System |
|---|---|
| New Zealand | 6 |
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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