Patients With an Implanted S-ICD Who Continue to Exercise RegularlySPORT-SICDNCT05754138
Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator
An observational study of Patients With an Implanted S-ICD Who Continue to Exercise Regularly, run by Eli Sprecher, MD at 1 site in Israel.
Trial summary
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Patients With an Implanted S-ICD Who Continue to Exercise Regularly
- What is being tested?
- Sport SICD
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2023to 1 Jan 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Child, Adult
Study population: patients with an implanted S-ICD as their first implanted device, who continue to exercise regularly and actively participate in competitive or recreational sports with a sport-intensity above a predefined level
Who may be able to join
- Patient (male or female) is <60 years of age.
- Patient has an implanted with a new-generation S-ICD [Boston Scientific EMBLEM, Generations 2 (model A209), 3 (A219) or newer].
- Present device is the first defibrillator implanted.
- Patient has a functioning LATITUDE™ Home-Monitoring-System at home, knows how to use it and sends weekly reports via the home-monitoring system.
- Patient actively participates in sport activities above a predefined level of exercise (see below).
- 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.
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- 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.
- Patient understands that The Sport S-ICD Study investigator neither encourage nor discourage performance of any given sport.
- 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.
- 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:
- Clinical data (age, gender, clinical diagnosis, indication for S-ICD implantation, arrhythmic events since S-ICD implantation, adverse events since S-ICD implantation)
- Type and level of exercise and sport participation at the time of inclusion and during follow-up.
- Information concerning endpoint events during follow-up.
- 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.
Who cannot join
- Subjects with an inability to communicate well with the investigators.
- Subjects who are non-cooperative or unwilling to sign consent form.
- Evidence suggestive of malfunction of the implanted S-ICD system (like abnormal impedance or detected noise) at the time of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sami Viskin, Prof contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Ehud Chorin, 972527360498, udichorin5@gmail.com
Ehud Chorin
About this study
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
Read the detailed description
Observational multicenter study with prospective follow-up but accepting also retrospectively collected data. Data will be collected and entered in a secure dedicated web-based database.
- Being tested
- Sport SICD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sport SICDDevice
Follow up
| Study group | Role | What they receive |
|---|---|---|
| study population | The study population will consist of patients with an implanted S-ICD as their first implanted device, who continue to exercise regularly and actively participate in competitive or recreational sports with a sport-intensity above a predefined level Receives: Device: Sport SICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tachyarrhythmia-related death or externally resuscitated cardiac arrest due to S-ICD
Quantitative data will be reported by S-ICD interrogation including shock failure, incessant ventricular arrhythmia, or post-shock pulseless electrical activity.
Measured: 5 years
Secondary outcomes (1)
S-ICD Lead fracture/malfunction
Noise/impedance will be reported by S-ICD interrogation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With an Implanted S-ICD Who Continue to Exercise RegularlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Eli Sprecher, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754138
- Sponsor's protocol ID
- 0132-22-tlv
- Acronym
- SPORT-SICD
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT05754138
- Acronym / sponsor ID
- SPORT-SICD / 0132-22-tlv
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eli Sprecher, MDOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
Detailed description
Observational multicenter study with prospective follow-up but accepting also retrospectively collected data. Data will be collected and entered in a secure dedicated web-based database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | Device: Sport SICDThe study population will consist of patients with an implanted S-ICD as their first implanted device, who continue to exercise regularly and actively participate in competitive or recreational sports with a sport-intensity above a predefined level |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients with an implanted S-ICD as their first implanted device, who continue to exercise regularly and actively participate in competitive or recreational sports with a sport-intensity above a predefined level
Key inclusion criteria (14 listed)
- Patient (male or female) is <60 years of age.
- Patient has an implanted with a new-generation S-ICD [Boston Scientific EMBLEM, Generations 2 (model A209), 3 (A219) or newer].
- Present device is the first defibrillator implanted.
- Patient has a functioning LATITUDE™ Home-Monitoring-System at home, knows how to use it and sends weekly reports via the home-monitoring system.
- Patient actively participates in sport activities above a predefined level of exercise (see below).
Key exclusion criteria (3 listed)
- Subjects with an inability to communicate well with the investigators.
- Subjects who are non-cooperative or unwilling to sign consent form.
- Evidence suggestive of malfunction of the implanted S-ICD system (like abnormal impedance or detected noise) at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sport SICDFollow up | Device | study population |
Primary outcome
Tachyarrhythmia-related death or externally resuscitated cardiac arrest due to S-ICD
Time frame: 5 years
Quantitative data will be reported by S-ICD interrogation including shock failure, incessant ventricular arrhythmia, or post-shock pulseless electrical activity.
1 secondary outcome
S-ICD Lead fracture/malfunction
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sami Viskin, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With an Implanted S-ICD Who Continue to Exercise Regularly, run by Eli Sprecher, MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ehud Chorin, Dr (972527360498, udichorin5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tachyarrhythmia-related death or externally resuscitated cardiac arrest due to S-ICD (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.