Chronic Heart Failure
Conditions
Keywords
Cardiac implantable electronic device, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, Machine learning, Mobile application, Patient's assistance
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.
Interventions
DIAGNOSTIC_TESTMultivariate assessment
Patient's status assessment according to clinical evaluation and data acquired from the implanted device.
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18-90 years old * Chronic heart failure (NYHA class I to III) * Implanted ICD or CRT (at least 30 days before inclusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Contacts
Primary ContactAndrzej Cacko, MD PhD
Outcome results
None listed