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

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: CRTD or ICD (Energen)

• Registration Number: NCT01501331
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-16
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RRT diagnostic tool	CRTD or ICD (Energen)	Patients implanted with an Energen device or successor.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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