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The Western Galilee Hospital in Nahariya Home Monitoring Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by ron sela, Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548755
First Posted: March 8, 2012
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ron sela, Western Galilee Hospital-Nahariya
  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 ron sela, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ron sela, Ron Sela, MD, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01548755     History of Changes
Other Study ID Numbers: HMR_Naharia
First Submitted: March 5, 2012
First Posted: March 8, 2012
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by ron sela, Western Galilee Hospital-Nahariya:
Home monitoring
cardiomessenger
ICD

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