Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766943
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-03-02
Brief Title:
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None