Clinical Workload Assessment Based Upon a Home Monitoring SystemNCT01154205
Sheba Medical Center Home Monitoring Clinic Registry
An observational study of Clinical Workload Assessment Based Upon a Home Monitoring System, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Workload Assessment Based Upon a Home Monitoring System
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with an ICD or CRTD.
Who may be able to join
- 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
Who cannot join
- no indication for ICD or CRTD implant
- Life expectancy shorter than 12 months
- Pregnancy
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Tel HaShomer, Ramat Gan, 52621
David Luria, MD
Michael Glikson, Professor
About this study
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients post implantation of ICD or CRTD | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Workload Assessment Based Upon a Home Monitoring SystemStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154205
- Sponsor's protocol ID
- SHEBA-09-7598-DL-CTIL
- Status last verified
- Jun 2010
- First submitted
- 29 Jun 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sheba Medical Center Home Monitoring Clinic Registry
- ClinicalTrials.gov ID
- NCT01154205
- Acronym / sponsor ID
- SHEBA-09-7598-DL-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2010
- Study completion
- Jan 2012 (estimated)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients post implantation of ICD or CRTD | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with an ICD or CRTD.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- no indication for ICD or CRTD implant
- Life expectancy shorter than 12 months
- Pregnancy
- Participation in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Workload Assessment Based Upon a Home Monitoring System, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Luria, MD (972-52-6667111, dluria@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.