Sheba Medical Center Home Monitoring Clinic Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Detailed Description

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Conditions

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Clinical Workload Assessment Based Upon a Home Monitoring System

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients post implantation of ICD or CRTD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Heart Center at Sheba Medical Center

Locations

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