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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766943

Collaborator

Boston Scientific Corporation (Industry), Yuji Ishida, MD (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subcutaneous ICD Myopotential Interference	Device: Smart Pass ON Device: Smart Pass OFF	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Smart Pass ON Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.	Device: Smart Pass ON Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Placebo Comparator: Smart Pass OFF Smart Pass filter will be programmed OFF 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.

Arm

Intervention/Treatment

Active Comparator: Smart Pass ON

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

Device: Smart Pass ON

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

Placebo Comparator: Smart Pass OFF

Smart Pass filter will be programmed OFF 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.

Outcome Measures

Primary Outcome Measures

The incidence of myopotential interference [throughout the intervention, approximately 20 minutes]
The incidence of myopotential interference, assessed by subcutaneous electrogram annotated "T" marker during the tube exercise test with or without Smart Pass filter

Secondary Outcome Measures

Incidence of MPI in US participants and Japanese participants [duration of enrollment, approximately 6 months]
Compare the differences in the incidence of myopotential interference in US and Japanese participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
Boston Scientific Corporation
Yuji Ishida, MD

Investigators

Principal Investigator: Michael R Gold, MD, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Gold, MD, Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05766943

Other Study ID Numbers:

00117025

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 17, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Michael Gold, MD, Professor, Medical University of South Carolina

Device interrogation

Study Results

No Results Posted as of Mar 17, 2023