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Sheba Medical Center Home Monitoring Clinic Registry

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ClinicalTrials.gov Identifier: NCT01154205
Recruitment Status : Unknown
Verified June 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 30, 2010
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:
Sheba Medical Center

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

Condition or disease
Clinical Workload Assessment Based Upon a Home Monitoring System

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sheba Medical Center Home Monitoring Clinic Registry
Study Start Date : June 2010
Estimated Study Completion Date : January 2012

Group/Cohort
Patients post implantation of ICD or CRTD




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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

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): NCT01154205


Contacts
Contact: David Luria, MD 972-52-6667111 dluria@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Tel HaShomer, Ramat Gan, Israel, 52621
Principal Investigator: David Luria, MD         
Sub-Investigator: Michael Glikson, Professor         
Sub-Investigator: David Bar Lev, MD         
Sub-Investigator: Osnat Gurevitz, MD         
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Dr. David Luria, Heart Center at Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01154205     History of Changes
Other Study ID Numbers: SHEBA-09-7598-DL-CTIL
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010