RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-06
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)
  1. * Less than 18 years of age
  2. * Hemodynamically unstable
  3. * Inability to preform TET due to orthopedic issues or cognitive impairment

Contacts and Locations

Study Contact

Debi Everidge
CONTACT
843-792-2944
adamsde@musc.edu
Kavin Panneerselvam
CONTACT
843-792-0464
panneeer@musc.edu

Principal Investigator

Michael R Gold, MD, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Michael R Gold, MD, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Device interrogation

Additional Relevant MeSH Terms

  • Subcutaneous ICD
  • Myopotential Interference