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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRT diagnostic tool | Patients implanted with an Energen device or successor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRTD or ICD (Energen) | Device | RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni B Forleo, MD, PhD | University of Rome Tor Vergata | Principal Investigator |
| Luca Santini, MD, PhD | University of Rome Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milan | Italy | |||||
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 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 |
| Rome |
| Italy |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |