Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure, Cardiac Resynchronization Therapy, Internal Cardioverter Defibrillators
Brief summary
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.
Interventions
DEVICECRTD or ICD (Energen)
RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators
Sponsors
University of Rome Tor Vergata
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms. | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) | 24 months | 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 |
| Correlation of RRT with appropriate ICD therapy (ATP or Shock) | 24 months | 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 |
| Correlation of RRT with atrial and ventricular arrhythmias | 24 months | 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 |
Countries
Italy
Outcome results
None listed