The Western Galilee Hospital in Nahariya Home Monitoring Registry

NCT ID: NCT01548755

Last Updated: 2012-03-13

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tachycardia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ron sela

OTHER_GOV

Sponsor Role lead

Responsible Party

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ron sela

Ron Sela, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ron Sela, MD

Role: PRINCIPAL_INVESTIGATOR

The Western Galilee Hospital in Nahariya

Locations

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The Western Galilee Hospital in Nahariya

Nahariya, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ron Sela, MD

Role: CONTACT

972 4 9107438

Facility Contacts

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Ron Sela, MD

Role: primary

972 4 9107438

Other Identifiers

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HMR_Naharia

Identifier Type: -

Identifier Source: org_study_id

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