Testing a device feature to reduce interference in heart monitoring
The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
This study is testing a new feature in heart monitoring devices to see if it can better tell the difference between muscle movements and heart signals during arm exercises for people who already have an implanted device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05766943 on ClinicalTrials.gov |
What this trial studies
This study involves participants who already have a subcutaneous ICD device implanted and are attending a routine follow-up appointment. The goal is to evaluate a feature that can distinguish between muscle movements and irregular heart signals during simple arm exercises. Participants will be randomly assigned to have this feature either activated or deactivated during the exercises, with data collected in both scenarios. The study requires only one visit for participation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have an EMBLEM S-ICD device implanted.
Not a fit: Patients who are hemodynamically unstable or unable to perform the required exercises due to orthopedic issues or cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of heart monitoring in patients with S-ICD devices.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Michael R Gold, MD, PhD — Medical University of South Carolina
- Study coordinator: Debi Everidge
- Email: adamsde@musc.edu
- Phone: 843-792-2944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.