Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05766943

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

Led by Medical University of South Carolina · Updated on 2026-01-13

71

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

D

Debi Everidge

CONTACT

K

Kavin Panneerselvam

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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