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The Western Galilee Hospital in Nahariya Home Monitoring Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
ron sela, Western Galilee Hospital-Nahariya Identifier:
First received: March 5, 2012
Last updated: March 12, 2012
Last verified: March 2012

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


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.

Further study details as provided by Western Galilee Hospital-Nahariya:

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ICD or CRTD implanted patient


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01548755

Contact: Ron Sela, MD 972 4 9107438

The Western Galilee Hospital in Nahariya Not yet recruiting
Nahariya, Israel
Contact: Ron Sela, MD    972 4 9107438   
Principal Investigator: Ron Sela, MD         
Sub-Investigator: Shaul Atar, MD         
Sponsors and Collaborators
ron sela
Principal Investigator: Ron Sela, MD The Western Galilee Hospital in Nahariya
  More Information

No publications provided

Responsible Party: ron sela, Ron Sela, MD, Western Galilee Hospital-Nahariya Identifier: NCT01548755     History of Changes
Other Study ID Numbers: HMR_Naharia
Study First Received: March 5, 2012
Last Updated: March 12, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Western Galilee Hospital-Nahariya:
Home monitoring
ICD processed this record on March 03, 2015