Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients

Study Overview
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Brief Summary
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The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.

Official Title
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Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: CRTD or ICD (Energen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor Able to provide written informed consent Exclusion Criteria: Life expectancy <12 months Anticipated non-compliance with the follow-up scheme Moderate to severe Chronic Obstructive Pulmonary Disease Primary pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RRT diagnostic tool<br>Patients implanted with an Energen device or successor. | Device: CRTD or ICD (Energen)<br>* RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms. | Respiratory rate changes (maximum, median and minimum values) before a primary event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) | Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis | 24 months | 
| Correlation of RRT with appropriate ICD therapy (ATP or Shock) | Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis | 24 months | 
| Correlation of RRT with atrial and ventricular arrhythmias | Respiratory rate changes (maximum, median and minimum values) before the event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Cardiac Resynchronization Therapy, Internal Cardioverter Defibrillators