Tel Aviv Sourasky MC Home Monitoring Clinic Registry

Tel Aviv Sourasky MC Home Monitoring Registry

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.

Study Overview

• Status: Completed
• Conditions: Home Monitoring With ICD Patient

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Electrophisiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICD or CRTD implanted patient

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICD implant

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Aharon Glik, MD, Tel Aviv Sourasky MC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HMR_TelAviv_sourasky

Plan for Individual participant data (IPD)

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