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

Not Applicable

Recruiting

• Conditions: Subcutaneous ICD; Myopotential Interference
• Interventions: Device: Smart Pass ON; Device: Smart Pass OFF

• Registration Number: NCT05766943
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Study Start: 2023-11-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States