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
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 13, 2026
January 1, 2026
3.2 years
March 2, 2023
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of MPI in US participants and Japanese participants
duration of enrollment, approximately 6 months
Study Arms (2)
Smart Pass ON
ACTIVE COMPARATORSmart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Smart Pass OFF
PLACEBO COMPARATORSmart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.
Interventions
Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)
You may not qualify if:
- Less than 18 years of age
- Hemodynamically unstable
- Inability to preform TET due to orthopedic issues or cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Gold, MD, PhD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 2, 2023
First Posted
March 13, 2023
Study Start
November 6, 2023
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share