NCT01516112

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Last Updated

January 24, 2012

Status Verified

July 1, 2011

First QC Date

January 19, 2012

Last Update Submit

January 19, 2012

Conditions

Keywords

ICD, home monitoring, cardiomessenger, implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with an ICD or CRTD.

You may qualify if:

  • 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

You may not qualify if:

  • no indication for ICD or CRTD implant
  • Life expectancy shorter than 12 months
  • Pregnancy
  • Participation in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir MC

Kfar Saba, Israel

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Israel Chetboun

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

February 1, 2012

Last Updated

January 24, 2012

Record last verified: 2011-07

Locations