The Western Galilee Hospital in Nahariya Home Monitoring Registry

March 12, 2012 updated by: ron sela

Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.

The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

Study Overview

Status

Unknown

Conditions

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).

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

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Nahariya, Israel
        • The Western Galilee Hospital in Nahariya
        • Sub-Investigator:
          • Shaul Atar, MD
        • Contact:
        • Principal Investigator:
          • Ron Sela, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICD or CRTD implanted patient

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ron sela

Investigators

  • Principal Investigator: Ron Sela, MD, The Western Galilee Hospital in Nahariya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR_Naharia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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