Actively Recruiting

Age: 10Years - 60Years
All Genders
NCT05754138

Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator

Led by Eli Sprecher, MD · Updated on 2023-03-03

500

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.

CONDITIONS

Official Title

Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator

Who Can Participate

Age: 10Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is male or female and under 60 years of age
  • Patient has a new-generation Boston Scientific EMBLEM S-ICD implanted
  • The present device is the patient's first defibrillator
  • Patient has a working LATITUDE Home-Monitoring System and sends weekly reports
  • Patient actively participates in sports above a certain exercise level
  • Patient understands the lack of data on sports safety with S-ICD and accepts responsibility for sport activities
  • Patient agrees that the study neither encourages nor discourages any sport
  • Patient understands the study is not liable for any damages from sport participation
  • Patient is willing to provide informed consent including clinical data, exercise information, and monitoring access
Not Eligible

You will not qualify if you...

  • Unable to communicate well with the investigators
  • Non-cooperative or unwilling to sign consent form
  • Evidence of malfunction of the implanted S-ICD system at screening (e.g., abnormal impedance or noise)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tel Aviv Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

E

Ehud Chorin, Dr

CONTACT

S

Sami Viskin, Prof

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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