Meir Medical Center Home Monitoring Clinic Registry

Patients Implanted With an ICD or CRTD. Clinical Trial

Official title:

Meir Medical Center Home Monitoring Clinic Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01516112
• Other study ID #: HMR-1.0-MEIR
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2012
• Last updated: January 19, 2012
• Start date: February 2012

Study information

• Verified date: July 2011
• Source: Meir Hospital, Kfar Saba, Israel
• Contact: Israel Chetboun, M.D
• Phone: +972-577482449
• Email: shetboun.israel[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Isral: Meir MC IRB
• 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: 20
• 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

• Patients Implanted With an ICD or CRTD.

Locations

Country	Name	City	State
Israel	Meir MC	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Hospital, Kfar Saba, Israel

Country where clinical trial is conducted

Israel,