NCT01548755

Brief Summary

The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Typical duration 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

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

First QC Date

March 5, 2012

Last Update Submit

March 12, 2012

Conditions

Tachycardia

Keywords

Home monitoringcardiomessengerICD

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICD or CRTD implanted patient

You may qualify if:

  • 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.

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)

The Western Galilee Hospital in Nahariya

Nahariya, Israel

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ron Sela, MD

    The Western Galilee Hospital in Nahariya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Sela, MD

CONTACT

972 4 9107438Ron.Sela@naharia.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ron Sela, MD

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

April 1, 2012

Study Completion

January 1, 2015

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

IL(1)