The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- The incidence of myopotential interference
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Smart Pass ON
Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Intervention: Smart Pass ON (Device)
Smart Pass OFF
Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.
Intervention: Smart Pass OFF (Device)
Outcomes
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(duration of enrollment, approximately 6 months)
Investigators
Michael Gold
Professor
Medical University of South Carolina