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

NCT ID: NCT05766943

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2026-12-31

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.

Conditions

Subcutaneous ICD; Myopotential Interference

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Smart Pass ON

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

Group Type: ACTIVE_COMPARATOR

Smart Pass ON

Intervention Type: DEVICE

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

Smart Pass OFF

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

Group Type: PLACEBO_COMPARATOR

Smart Pass OFF

Intervention Type: DEVICE

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

Interventions

Smart Pass ON

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

Intervention Type: DEVICE

Smart Pass OFF

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Michael Gold

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael R Gold, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Debi Everidge

Role: CONTACT

adamsde@musc.edu

843-792-2944

Kavin Panneerselvam

Role: CONTACT

panneeer@musc.edu

843-792-0464

Facility Contacts

Debi Everidge

Role: primary

adamsde@musc.edu

843-792-2944

Other Identifiers

00117025

Identifier Type: -

Identifier Source: org_study_id