NCT01501331 - Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients | Crick

Overview

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 Type

OBSERVATIONAL

Enrollment

180

Conditions

Congestive Heart Failure

Interventions

CRTD or ICD (Energen)DEVICE

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Milan, Italy

Unnamed facility

Rome, Italy

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 24 months