Sheba Medical Center Home Monitoring Clinic Registry | NCT01154205

Studies
Sheba Medical Center Home Monitoring Clinic Registry

NCT01154205

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 30, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Clinical Workload Assessment Based Upon a Home Monitoring System

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Not provided

Completion Date

Jan 2012Estimated

First Submitted Date

Jun 29, 2010

First Submission Date that Met QC Criteria

Jun 29, 2010

First Posted Date

Jun 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2010

Last Update Posted Date

Jun 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Patients post implantation of ICD or CRTD

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients implanted with an ICD or CRTD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Luria, MD	Contact	972-52-6667111		dluria@sheba.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky	Ramat Gan	52621	Israel