Tel Aviv Sourasky MC Home Monitoring Clinic 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.

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Key information

Conditions

Home Monitoring With ICD Patient

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Electrophisiology Department

Tel Aviv, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

Tel Aviv Sourasky MC Home Monitoring Registry

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Feb 28, 2012
Registry last updated: Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.