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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Myopotential Interference; Subcutaneous ICD

Treatments: Device: Smart Pass OFF; Device: Smart Pass ON

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05766943

00117025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

71 participants in 2 patient groups, including a placebo group

Smart Pass ON

Active Comparator group

Description:

Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.

Treatment:

Device: Smart Pass ON

Smart Pass OFF

Placebo Comparator group

Description:

Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

Treatment:

Device: Smart Pass OFF