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Meir Medical Center Home Monitoring Clinic Registry

This study is not yet open for participant recruitment.
Verified July 2011 by Meir Hospital, Kfar Saba, Israel
Sponsor:
Information provided by (Responsible Party):
chetboun israel, Meir Hospital, Kfar Saba, Israel
ClinicalTrials.gov Identifier:
NCT01516112
First received: January 19, 2012
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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


Condition
Patients Implanted With an ICD or CRTD.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Meir Medical Center Home Monitoring Clinic Registry

Further study details as provided by Meir Hospital, Kfar Saba, Israel:

Estimated Enrollment: 20
Study Start Date: February 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with an ICD or CRTD.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516112

Contacts
Contact: Israel Chetboun, M.D +972-577482449 shetboun.israel@clalit.org.il

Locations
Israel
Meir MC Not yet recruiting
Kefar Saba, Israel
Contact: Israel Chetboun, M.D.     +972-575482449     shetboun.israel@clalit.org.il    
Principal Investigator: Israel Chetboun, M.D            
Sponsors and Collaborators
Meir Hospital, Kfar Saba, Israel
  More Information

No publications provided

Responsible Party: chetboun israel, Dr. Israel Chetboun, Meir Hospital, Kfar Saba, Israel
ClinicalTrials.gov Identifier: NCT01516112     History of Changes
Other Study ID Numbers: HMR-1.0-MEIR
Study First Received: January 19, 2012
Last Updated: January 19, 2012
Health Authority: Isral: Meir MC IRB

Keywords provided by Meir Hospital, Kfar Saba, Israel:
ICD, home monitoring, cardiomessenger, implant

ClinicalTrials.gov processed this record on May 23, 2013