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Clinical Trials/NCT03474315
NCT03474315
Unknown
Not Applicable

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

Medical University of Warsaw1 site in 1 country600 target enrollmentApril 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Medical University of Warsaw
Enrollment
600
Locations
1
Primary Endpoint
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2018
End Date
February 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

Marcin Grabowski

Clinical Professor

Medical University of Warsaw

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Ambulatory visit qualified as meaningful due to alarming condition related to ICD.(1 day)

Study Sites (1)

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