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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01548755
Other study ID # HMR_Naharia
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 5, 2012
Last updated March 12, 2012
Start date April 2012
Est. completion date January 2015

Study information

Verified date March 2012
Source Western Galilee Hospital-Nahariya
Contact Ron Sela, MD
Phone 972 4 9107438
Email Ron.Sela@naharia.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date January 2015
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel The Western Galilee Hospital in Nahariya Nahariya

Sponsors (1)

Lead Sponsor Collaborator
ron sela

Country where clinical trial is conducted

Israel, 

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