Clinical trial Recruiting at 1 site Observational Ages 10 to 60

Safety of sports for patients with a subcutaneous implantable cardioverter defibrillator

Run by Tel-Aviv Sourasky Medical Center · NCT05754138 · Data updated 2026-11-12

This study looks at whether it's safe for people with a subcutaneous implantable cardioverter defibrillator to participate in different sports and how regular exercise affects them.

Quick facts

Study typeObservational
Ages10 Years to 60 Years
SexAll
Enrollment500 (estimated)
SponsorTel-Aviv Sourasky Medical Center
Government
Locations1 site (Tel Aviv)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedJanuary 1, 2026
Study endsJanuary 1, 2029
Registry record updatedMarch 3, 2023
Trial IDNCT05754138 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients under 60 years of age with a new-generation S-ICD who actively participate in sports.

Probably not a fit

Patients over 60 years of age or those without a functioning LATITUDE™ Home-Monitoring-System may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to collect data on the safety of sports activities for patients who have a subcutaneous implantable cardioverter defibrillator (S-ICD) implanted. It will involve both prospective follow-up and retrospective data collection, with information entered into a secure web-based database. The study focuses on understanding how regular exercise impacts patients with this device, particularly regarding the safety and potential risks associated with various sports activities.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety of sports participation for patients with S-ICDs, potentially guiding future recommendations for exercise in this population.

How similar studies have gone: While there is limited data on the safety of sports for patients with S-ICDs, this study represents a novel approach to understanding this issue.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patient (male or female) is \<60 years of age.
2. Patient has an implanted with a new-generation S-ICD \[Boston Scientific EMBLEM, Generations 2 (model A209), 3 (A219) or newer\].
3. Present device is the first defibrillator implanted.
4. Patient has a functioning LATITUDE™ Home-Monitoring-System at home, knows how to use it and sends weekly reports via the home-monitoring system.
5. Patient actively participates in sport activities above a predefined level of exercise (see below).
6. Patient understands that, at present, there is virtually no data on the safety of sport participation for patients with implanted S-ICD system, particularly regarding potential damage caused by sport activities to the S-ICD system, including the subcutaneous electrode.
7. Patient understands that the level of sport activity, type of sport and frequency of exercise activities are entirely at his/her own discretion and responsibility.
8. Patient understands that The Sport S-ICD Study investigator neither encourage nor discourage performance of any given sport.
9. Patient understands that The Sport S-ICD Study is not liable for- and does assume any responsibility for any damages caused by sport participation to the implanted system or the health of patients participating in the study.
10. Patient is willing to provide informed consent to participate in the SPORT S-ICD Study. Informed consent includes agreement to provide all the following information:

    1. Clinical data (age, gender, clinical diagnosis, indication for S-ICD implantation, arrhythmic events since S-ICD implantation, adverse events since S-ICD implantation)
    2. Type and level of exercise and sport participation at the time of inclusion and during follow-up.
    3. Information concerning endpoint events during follow-up.
    4. Direct access to the patients' LATITUDE™ Home-Monitoring-System data, both at the time of inclusion and all weekly reports during the follow-up period, until the study ends or the informed consent is revoked. Access to the personal LATITUDE™ Home-Monitoring-System data is in addition to the access by the primary treating physician and only for purpose of data collection for the study. Consent from the patient AND for the primary treating physician (monitoring the patient's LATITUDE data) are required. Once the study ends, participating patients will be notified that the Study Investigators are no longer monitoring his/her LATITUDE Home-Monitoring-System.

Exclusion Criteria:

1. Subjects with an inability to communicate well with the investigators.
2. Subjects who are non-cooperative or unwilling to sign consent form.
3. Evidence suggestive of malfunction of the implanted S-ICD system (like abnormal impedance or detected noise) at the time of screening

Where it's running

  • Tel Aviv Medical Center
    Tel Aviv, Israel
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.