- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516112
Meir Medical Center Home Monitoring Clinic Registry
January 19, 2012 updated by: chetboun israel, Meir Hospital, Kfar Saba, Israel
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kefar Saba, Israel
- Meir MC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients implanted with an ICD or CRTD.
Description
Inclusion Criteria:
- Approved indication for ICD or CRTD
- Implanted with or replaced with a Biotronik Lumax device
- Patient 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 follow up
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (ESTIMATE)
January 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 24, 2012
Last Update Submitted That Met QC Criteria
January 19, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- HMR-1.0-MEIR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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