NCT05766943

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Subcutaneous ICD
• Myopotential Interference

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-06
• Primary completion: 2026-12-30
• Completion: 2026-12-31
• First posted: 2023-03-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study