Interactive Patient's Assistant - LUCY

• Conditions: Chronic Heart Failure
• Interventions: Diagnostic Test: Multivariate assessment

• Registration Number: NCT03474315
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-13
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-14
• Last Update Submitted: 2018-03-14
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22
• Study Start: 2018-04
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHF and CIED patients	Multivariate assessment	600 CHF patients with ICD or CRT admitted to regulatory ambulatory visit.

Primary Outcome Measures

Name	Time	Method
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Ambulatory visit qualified as meaningful due to alarming condition related to ICD.	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.

Trial Locations

Locations (1)

Department of Medical Informatics and Telemedicine; 🇵🇱 Warsaw, Mazowieckie, Poland