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

Recruiting now · Not applicable

Conditions studied: Subcutaneous ICD, Myopotential Interference

In brief

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.

Key facts

Study ID

NCT05766943

Run by

Medical University of South Carolina

People needed

71

Starts

2023-11-06

Expected to finish

2026-12-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)

You may not qualify if…

• Less than 18 years of age
• Hemodynamically unstable
• Inability to preform TET due to orthopedic issues or cognitive impairment

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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