Tel Aviv Sourasky MC Home Monitoring Clinic Registry

Completed

• Conditions: Home Monitoring With ICD Patient

• Registration Number: NCT01540149
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.

Detailed Description

EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.

Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Study Start: 2012-08
• Primary Completion: 2014-10
• Study Completion: 2015-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Approved indication for ICD or CRTD.
• Implanted with or replaced with a Biotronik Lumax device.
• Patient is willing and able to sign consent form.
• Willing and able to attend clinic visits and follow up schedule.
• Transmission of more than 80% at 3-month FU.
• Patient older than 18 years.

Exclusion Criteria

• No indication for ICD or CRTD implant.
• Life expectancy shorter than 12 months.
• Pregnancy.
• Participation in other clinical studies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Electrophisiology Department; 🇮🇱 Tel Aviv, Israel