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

NCT05766943 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-01-13

No results posted yet for this study

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

Interventions

DEVICE

Smart Pass ON

Smart Pass filter will be programmed ON 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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Michael R Gold, MD, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-12-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766943 on ClinicalTrials.gov