Reduction of Myopotential Interference With Smart Pass in S-ICD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Following this visit study participation is complete.

Official Title
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The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference

Conditions
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Subcutaneous ICD, Myopotential Interference

Intervention / Treatment
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* Device: Smart Pass ON
* Device: Smart Pass OFF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smart Pass ON<br>Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing. | Device: Smart Pass ON<br>* Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.<br>|
| Placebo Comparator: Smart Pass OFF<br>Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing. | Device: Smart Pass OFF<br>* Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Device interrogation