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Meir Medical Center Home Monitoring Clinic Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by chetboun israel, Meir Hospital, Kfar Saba, Israel.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516112
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
chetboun israel, Meir Hospital, Kfar Saba, Israel
  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 chetboun israel, Meir Hospital, Kfar Saba, Israel:

Estimated Enrollment: 20
Study Start Date: February 2012
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 19, 2012
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
Last Verified: July 2011

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