Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Meir Medical Center Home Monitoring Clinic Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Meir Hospital, Kfar Saba, Israel.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
chetboun israel, Meir Hospital, Kfar Saba, Israel Identifier:
First received: January 19, 2012
Last updated: NA
Last verified: July 2011
History: No changes posted

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

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

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.


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01516112

Contact: Israel Chetboun, M.D +972-577482449

Meir MC Not yet recruiting
Kefar Saba, Israel
Contact: Israel Chetboun, M.D.    +972-575482449   
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 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 processed this record on March 03, 2015