Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05766943
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- At least 18 years of age
- Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)
Exclusion criteria
- Less than 18 years of age
- Hemodynamically unstable
- Inability to preform TET due to orthopedic issues or cognitive impairment
Treatment and study plan
Smart Pass ON
DeviceSmart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Smart Pass OFF
DeviceSmart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.
Primary outcomes
-
The incidence of myopotential interference
Time frame: throughout the intervention, approximately 20 minutes
The incidence of myopotential interference, assessed by subcutaneous electrogram annotated "T" marker during the tube exercise test with or without Smart Pass filter
Secondary outcomes
-
Incidence of MPI in US participants and Japanese participants
Time frame: duration of enrollment, approximately 6 months
Compare the differences in the incidence of myopotential interference in US and Japanese participants
Study contacts
Contact information is provided by the study sponsor or research team.
Debi Everidge
CONTACT
Kavin Panneerselvam
CONTACT
Sponsors and collaborators
Lead sponsor
Medical University of South Carolina
Other
Collaborators
- Boston Scientific Corporation
Registry information
Official study title
The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 13, 2023
- Registry last updated
- Jan 13, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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