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Smart Pass Feature for S-ICD Performance

N/A
Recruiting
Led By Michael R Gold, MD, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of enrollment, approximately 6 months
Awards & highlights

Study Summary

This trial is testing a feature on an S-ICD device to see if it can recognize arm movement and differentiate it from irregular heart signals. Participants exercise while having device data collected. One visit only.

Who is the study for?
This trial is for adults over 18 with an EMBLEM S-ICD (specific models A209 or A219) from Boston Scientific. It's not suitable for those who are hemodynamically unstable, unable to do simple arm exercises due to orthopedic or cognitive issues.Check my eligibility
What is being tested?
The study tests a feature in the S-ICD device that distinguishes muscle movements from heart signals during arm exercises. Participants will have this 'Smart Pass' feature turned on and off in random order during one clinic visit.See study design
What are the potential side effects?
Since the intervention involves only a device feature being turned on or off, there are no direct side effects like you'd expect with medication. However, discomfort from exercise may occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of enrollment, approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of enrollment, approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of myopotential interference
Secondary outcome measures
Incidence of MPI in US participants and Japanese participants

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Smart Pass ONActive Control1 Intervention
Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
Group II: Smart Pass OFFPlacebo Group1 Intervention
Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
720 Previous Clinical Trials
932,951 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,565 Total Patients Enrolled
Yuji Ishida, MDUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities in this clinical trial?

"Information hosted on clinicaltrials.gov shows that this research initiative has concluded its recruitment process, with the initial posting being made March 1st 2023 and its last edit occuring a day later. Nonetheless, there are currently two other trials actively searching for candidates."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
Michael Gold, MD 2023. "Reduction of Myopotential Interference With Smart Pass in S-ICD Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766943.
~20 spots leftby Jun 2024
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