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Tel Aviv Sourasky MC Home Monitoring Clinic Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540149
First Posted: February 28, 2012
Last Update Posted: July 7, 2016
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):
Tel-Aviv Sourasky Medical Center
  Purpose
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.

Condition
Home Monitoring With ICD Patient

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tel Aviv Sourasky MC Home Monitoring Registry

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Enrollment: 45
Study Start Date: August 2012
Study Completion Date: August 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICD implant

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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): NCT01540149


Locations
Israel
Electrophisiology Department
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Aharon Glik, MD Tel Aviv Sourasky MC
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01540149     History of Changes
Other Study ID Numbers: HMR_TelAviv_sourasky
First Submitted: February 22, 2012
First Posted: February 28, 2012
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No