Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sport SICD | Device | Follow up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| S-ICD Lead fracture/malfunction | Noise/impedance will be reported by S-ICD interrogation | 5 years |
Not provided
Inclusion Criteria:
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 LATITUDEâ„¢ 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.
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehud Chorin, Dr | Contact | 972527360498 | udichorin5@gmail.com | |
| Sami Viskin, Prof | Contact | samiviskin@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center | Recruiting | Tel Aviv | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided