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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.
This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially, then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit. Following this visit study participation is complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart Pass ON | Active Comparator | Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing. |
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| Smart Pass OFF | Placebo Comparator | Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Pass ON | Device | Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of myopotential interference | The incidence of myopotential interference, assessed by subcutaneous electrogram annotated "T" marker during the tube exercise test with or without Smart Pass filter | throughout the intervention, approximately 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MPI in US participants and Japanese participants | Compare the differences in the incidence of myopotential interference in US and Japanese participants | duration of enrollment, approximately 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debi Everidge | Contact | 843-792-2944 | adamsde@musc.edu | |
| Kavin Panneerselvam | Contact | 843-792-0464 | panneeer@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael R Gold, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Smart Pass OFF | Device | Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing. |
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