Sheba Medical Center Home Monitoring Clinic Registry

Clinical Workload Assessment Based Upon a Home Monitoring System Clinical Trial

Official title:

Sheba Medical Center Home Monitoring Clinic Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01154205
• Other study ID #: SHEBA-09-7598-DL-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 29, 2010
• Last updated: June 29, 2010
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2010
• Source: Sheba Medical Center
• Contact: David Luria, MD
• Phone: 972-52-6667111
• Email: dluria[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Approved indication for ICD or CRTD

• Implanted with or replaced with a Biotronik Lumax device

• Patient 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 follow up

• 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

• Clinical Workload Assessment Based Upon a Home Monitoring System

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,