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Sheba 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 June 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154205
First Posted: June 30, 2010
Last Update Posted: June 30, 2010
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:
Sheba Medical Center
  Purpose
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Condition
Clinical Workload Assessment Based Upon a Home Monitoring System

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

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: January 2012
Groups/Cohorts
Patients post implantation of ICD or CRTD

  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): 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
  More Information

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 Submitted: June 29, 2010
First Posted: June 30, 2010
Last Update Posted: June 30, 2010
Last Verified: June 2010