Interactive Patient's Assistant - LUCY

March 14, 2018 updated by: Marcin Grabowski, Medical University of Warsaw

Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up

Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.

Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

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

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • Department of Medical Informatics and Telemedicine

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be consisted of one patient group: 600 CHF patients with implanted ICD or CRT admitted to regulatory ambulatory visit.

Description

Inclusion Criteria:

  • 18-90 years old
  • Chronic heart failure (NYHA class I to III)
  • Implanted ICD or CRT (at least 30 days before inclusion)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHF and CIED patients
600 CHF patients with ICD or CRT admitted to regulatory ambulatory visit.
Diagnostic test: Multivariate assessment
Patient's status assessment according to clinical evaluation and data acquired from the implanted device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.
Time Frame: 1 day

Primary outcome is composed of:

  • any change in pharmacotherapy (modification of agents or doses) related to patient's clinical status assessed during the visit,
  • any change in tachyarrythmia counter or discriminator status,
  • any change in tachyarrythmia threshold,
  • ventricular undersensing or oversensing.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory visit qualified as meaningful due to alarming condition related to ICD.
Time Frame: 1 day

Secondary outcome is composed of:

  • sustained or treated ventricular tachyarrythmia,
  • any not previously diagnosed supraventricular tachyarrythmia,
  • elective replacement indicator,
  • atrial undersensing or oversensing,
  • atrial or ventricular ineffective pacing.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

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 (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUCY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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