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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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Smart Pass ON (device)
• Smart Pass OFF (device)

Sponsor: Medical University of South Carolina · Participants: 71 · Started: Nov 6, 2023

Contact the study team

• Debi Everidge · Phone: 843-792-2944
• Kavin Panneerselvam · Phone: 843-792-0464

Official record on ClinicalTrials.gov — NCT05766943

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.