RecruitingNot ApplicableNCT05766943

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

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


Sponsor

Medical University of South Carolina

Enrollment

71 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria3

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

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Interventions

DEVICESmart Pass ON

Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.

DEVICESmart Pass OFF

Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05766943