Multiparametric Evaluation of Heart Failure in Device-implanted Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Primary Endpoint
- Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
Time Frame: 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 Outcomes
- Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)(24 months)
- Correlation of RRT with appropriate ICD therapy (ATP or Shock)(24 months)
- Correlation of RRT with atrial and ventricular arrhythmias(24 months)
Investigators
Giovanni B Forleo
MD, PhD
University of Rome Tor Vergata