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The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-ICD System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous implantable defibrillator (S-ICD) system | Device | implantable defibrillator system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion of Induced Ventricular Fibrillation | The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation. | Testing done during the implant procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen O'Connor, PhD, Hon FRCP | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico San Donato | San Donato Milanese | 20097 | Italy | |||
| Academisch Medisch Centrum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26148819 | Derived | Theuns DA, Crozier IG, Barr CS, Hood MA, Cappato R, Knops RE, Maass AH, Boersma LV, Jordaens L. Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1159-63. doi: 10.1161/CIRCEP.115.002953. Epub 2015 Jul 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | S-ICD System | Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amsterdam |
| 1100 DD |
| Netherlands |
| Universitair Medisch Centrum | Groningen | 9713 GZ | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 GD | Netherlands |
| Auckland City Hospital | Auckland | 1001 | New Zealand |
| Christchurch Hospital | Christchurch | 8002 | New Zealand |
| Russells Hall Hospital | Dudley | DY1 2HQ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
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| ID | Title | Description |
|---|---|---|
| BG000 | S-ICD System | Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Conversion of Induced Ventricular Fibrillation | The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation. | Investigator induce sustained ventricular fibrillation conversion efficacy. Two of the 55 subjects implanted did not induce sustained ventricular fibrillation leaving 53 evaluable subjects. | Posted | Count of Participants | Participants | Testing done during the implant procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S-ICD System | Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system. | 1 | 55 | 17 | 55 | 4 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other - Adverse Event Terms Unknown | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other - Adverse Event Terms Unknown | General disorders |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Stoltz, Clinical Trial Manager | Boston Scientific | 1-800-227-3422 | thomas.stoltz@bsci.com |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| New Zealander, European |
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| Maori |
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| Indian |
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| Asian |
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| Italy |
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| United Kingdom |
|