Sheba Medical Center Home Monitoring Clinic Registry

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Sheba Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01154205

First received: June 29, 2010

Last updated: NA

Last verified: June 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 29, 2010

Last Updated Date

June 29, 2010

Start Date ^ICMJE

June 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sheba Medical Center Home Monitoring Clinic Registry

Official Title ^ICMJE

Sheba Medical Center Home Monitoring Clinic Registry

Brief Summary

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with an ICD or CRTD.

Condition ^ICMJE

Clinical Workload Assessment Based Upon a Home Monitoring System

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients post implantation of ICD or CRTD

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2012

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David Luria, MD

972-52-6667111

dluria@sheba.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01154205

Other Study ID Numbers ^ICMJE

SHEBA-09-7598-DL-CTIL

Has Data Monitoring Committee

Responsible Party

Dr. David Luria, Heart Center at Sheba Medical Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Sheba Medical Center

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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