Interactive Patient's Assistant - LUCY

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03474315
• Other study ID #: LUCY
• Status: Not yet recruiting
• First received: December 13, 2017
• Last updated: March 14, 2018
• Start date: April 2018
• Est. completion date: February 2019

Study information

• Verified date: March 2018
• Source: Medical University of Warsaw
• Contact: Andrzej Cacko, MD PhD
• Phone: +48 509892324
• Email: andrzej.cacko[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 years old

• Chronic heart failure (NYHA class I to III)

• Implanted ICD or CRT (at least 30 days before inclusion)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• Multivariate assessment
Patient's status assessment according to clinical evaluation and data acquired from the implanted device.

Locations

Country	Name	City	State
Poland	Department of Medical Informatics and Telemedicine	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.	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	Ambulatory visit qualified as meaningful due to alarming condition related to ICD.	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