Home Monitoring With ICD PatientNCT01540149
Tel Aviv Sourasky MC Home Monitoring Clinic Registry
An observational study of Home Monitoring With ICD Patient, run by Tel-Aviv Sourasky 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 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Home Monitoring With ICD Patient
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD or CRTD implanted patient
Who may be able to join
- Approved indication for ICD or CRTD.
- Implanted with or replaced with a Biotronik Lumax device.
- Patient is 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 FU.
- 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.
About this study
Official title: Tel Aviv Sourasky MC Home Monitoring Registry
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.
Read the detailed description
EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.
Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).
- Conditions
- Home Monitoring With ICD Patient
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 |
|---|---|---|
| ICD implant | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Monitoring With ICD PatientStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aharon Glik, MD, Principal investigator, Tel Aviv Sourasky MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540149
- Sponsor's protocol ID
- HMR_TelAviv_sourasky
- Status last verified
- Jul 2016
- First submitted
- 22 Feb 2012
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tel Aviv Sourasky MC Home Monitoring Registry
- ClinicalTrials.gov ID
- NCT01540149
- Acronym / sponsor ID
- HMR_TelAviv_sourasky
- Conditions
- Home Monitoring With ICD Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Feb 2012 (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 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.
Detailed description
EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.
Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD implant | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD or CRTD implanted patient
Key inclusion criteria (6 listed)
- Approved indication for ICD or CRTD.
- Implanted with or replaced with a Biotronik Lumax device.
- Patient is 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 FU.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
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.
Aharon Glik, MD principal investigator
Tel Aviv Sourasky MC
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 Home Monitoring With ICD Patient, run by Tel-Aviv Sourasky 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: finished, as of the sponsor's last update on 7 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 7 Jul 2016.