Tel Aviv Sourasky MC Home Monitoring Clinic Registry

Home Monitoring With ICD Patient Clinical Trial

Official title:

Tel Aviv Sourasky MC Home Monitoring Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540149
• Other study ID #: HMR_TelAviv_sourasky
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: July 6, 2016
• Start date: August 2012
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Home Monitoring With ICD Patient

Locations

Country	Name	City	State
Israel	Electrophisiology Department	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel,