Tel Aviv Sourasky MC Home Monitoring Clinic Registry

Tel Aviv Sourasky MC Home Monitoring Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01540149

Enrollment

Registered

2012-02-28

Start date

2012-08-31

Completion date

2015-08-31

Last updated

2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Home Monitoring With ICD Patient

Brief 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.

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Countries

Israel

Outcome results