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The Western Galilee Hospital in Nahariya Home Monitoring Registry

This study is not yet open for participant recruitment.
Verified March 2012 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by (Responsible Party):
ron sela, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01548755
First received: March 5, 2012
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition
Tachycardia

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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548755

Contacts
Contact: Ron Sela, MD 972 4 9107438 Ron.Sela@naharia.health.gov.il

Locations
Israel
The Western Galilee Hospital in Nahariya Not yet recruiting
Nahariya, Israel
Contact: Ron Sela, MD     972 4 9107438     Ron.Sela@naharia.health.gov.il    
Principal Investigator: Ron Sela, MD            
Sub-Investigator: Shaul Atar, MD            
Sponsors and Collaborators
ron sela
Investigators
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
ClinicalTrials.gov 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
cardiomessenger
ICD

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013