Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator

NCT05754138 | Recruiting

• 1 other identifier: 0132-22-tlv
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients With an Implanted S-ICD Who Continue to Exercise Regularly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• S-ICD Lead fracture/malfunction

  5 years

Study Arms (1)

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

Interventions

Sport SICD DEVICE

Follow up

study population

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.
• 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)
• Information concerning endpoint events during follow-up.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Sprecher, MD: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

Central Study Contacts

Ehud Chorin, Dr

CONTACT

972527360498; udichorin5@gmail.com

Sami Viskin, Prof

CONTACT

samiviskin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director general for R&D

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 3, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)