Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart Pass ON, Smart Pass OFF.
- Who it may be relevant to
- Registry conditions: Subcutaneous ICD, Myopotential Interference. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
Overview
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.
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.
Primary outcome measures
- The incidence of myopotential interference [Time frame: throughout the intervention, approximately 20 minutes]
Secondary outcome measures (1)
- Incidence of MPI in US participants and Japanese participants [Time frame: duration of enrollment, approximately 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT05766943 · 00117025