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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
Recruitment status was: Not yet recruiting
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01154205
First received: June 29, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
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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| 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
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 ClinicalTrials.gov identifier: NCT01154205
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 29, 2010 |
| Last Updated: | June 29, 2010 |
ClinicalTrials.gov processed this record on August 16, 2017