Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator (SPORT-SICD)

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

Study Overview

• Status: Recruiting
• Conditions: Patients With an Implanted S-ICD Who Continue to Exercise Regularly
• Intervention / Treatment: Device: Sport SICD

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Ehud Chorin, Dr; Phone Number: 972527360498; Email: udichorin5@gmail.com
• Study Contact Backup: Name: Sami Viskin, Prof; Email: samiviskin@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Medical Center
    • Contact: Ehud Chorin; Phone Number: 972527360498; Email: udichorin5@gmail.com
    • Principal Investigator: Ehud Chorin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Sport SICD; Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S-ICD Lead fracture/malfunction	Noise/impedance will be reported by S-ICD interrogation	5 years

Collaborators and Investigators

• Sponsor: Eli Sprecher, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2029

Study Registration Dates

• First Submitted: February 11, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0132-22-tlv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No