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

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.

Study Overview

• Status: Recruiting
• Conditions: Subcutaneous ICD; Myopotential Interference
• Intervention / Treatment: Device: Smart Pass ON; Device: Smart Pass OFF

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 Type: Interventional
• Enrollment (Estimated): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debi Everidge; Phone Number: 843-792-2944; Email: adamsde@musc.edu
• Study Contact Backup: Name: Kavin Panneerselvam; Phone Number: 843-792-0464; Email: panneeer@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Debi Everidge; Phone Number: 843-792-2944; Email: adamsde@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Smart Pass ON; Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.	Device: Smart Pass ON; Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Placebo Comparator: Smart Pass OFF; Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.	Device: Smart Pass OFF; Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael R Gold, MD, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Device interrogation
• Other Study ID Numbers: 00117025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No