Back to Trials
NCT05766943NARecruiting

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

Medical University of South Carolina

Start Date

11/6/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Smart Pass ON

DEVICE

Smart Pass OFF

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Subcutaneous ICDMyopotential Interference

Locations

Medical University of South Carolina

Charleston, South Carolina 29425

United States