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

University of Rome Tor Vergata

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: CRTD or ICD (Energen)

Study type: Observational

Funder types: Other

Identifiers

NCT01501331

PTVCARDIO2011_01

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

RRT diagnostic tool

Description:

Patients implanted with an Energen device or successor.

Treatment:

Device: CRTD or ICD (Energen)