CompletedNCT01540149Updated Jul 7, 2016

Tel Aviv Sourasky MC Home Monitoring Clinic Registry

An observational study in Home Monitoring With ICD Patient, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-07.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 45
Ages: 18 Years to 85 Years
Sex: All

Study 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 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 studied

Home Monitoring With ICD Patient

In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.

Browse Tel-Aviv Sourasky Medical Center studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

ICD or CRTD implanted patient

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

No indication for ICD or CRTD implant.
Life expectancy shorter than 12 months.
Pregnancy.
Participation in other clinical studies.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 45 participants (actual)

Groups and cohorts

ICD implant

Study locations

1 site

Electrophisiology Department
Tel Aviv, Israel

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Oct 2014 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 22, 2012
First posted: Feb 28, 2012
Start: Aug 2012
Primary completionActual: Oct 2014
CompletionActual: Aug 2015
Last update: Jul 7, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01540149
Lead sponsor: Tel-Aviv Sourasky Medical Center
Responsible party: Sponsor
First posted: Feb 28, 2012
Start date: Aug 2012
Primary completion: Oct 2014
Completion: Aug 2015
Last update: Jul 7, 2016

Study contacts

Aharon Glik, MD

principal investigator · Tel Aviv Sourasky MC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Tel-Aviv Sourasky Medical Center →

Start the discussion