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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05766943

Enrollment

Registered

2023-03-13

Start date

2023-11-06

Completion date

2026-12-31

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopotential Interference, Subcutaneous ICD

Keywords

Device interrogation

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of myopotential interference	throughout the intervention, approximately 20 minutes	The incidence of myopotential interference, assessed by subcutaneous electrogram annotated T marker during the tube exercise test with or without Smart Pass filter

Secondary

Measure	Time frame	Description
Incidence of MPI in US participants and Japanese participants	duration of enrollment, approximately 6 months	Compare the differences in the incidence of myopotential interference in US and Japanese participants

Countries

United States

Contacts

Primary ContactDebi Everidge

adamsde@musc.edu843-792-2944

Backup ContactKavin Panneerselvam

panneeer@musc.edu843-792-0464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026