Recruiting

Smart Pass

Sponsor:

Medical University of South Carolina

Code:

NCT05766943

Conditions

Subcutaneous ICD

Myopotential Interference

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smart Pass ON

Smart Pass OFF

Study Details

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.

Conditions

Subcutaneous ICD

Myopotential Interference

Study ID

NCT05766943

Start date

Nov 6, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

71 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

Interventions

Smart Pass ON

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.

Primary outcome measure

  • The incidence of myopotential interference [ Time Frame: throughout the intervention, approximately 20 minutes ]

Central Contacts and Locations

Central contacts

Debi Everidge

843-792-2944adamsde@musc.edu

Kavin Panneerselvam

843-792-0464panneeer@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Debi Everidge

843-792-2944adamsde@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • Device interrogation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-01-13.