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

NCT01501331 | Completed

• 1 other identifier: PTVCARDIO2011_01
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Cardiac Resynchronization Therapy; Internal Cardioverter Defibrillators

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

RRT diagnostic tool

Patients implanted with an Energen device or successor.

Device: CRTD or ICD (Energen)

Interventions

CRTD or ICD (Energen) DEVICE

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

RRT diagnostic tool

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool

You may qualify if:

• 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

You may not qualify if:

• Life expectancy \<12 months
• Anticipated non-compliance with the follow-up scheme
• Moderate to severe Chronic Obstructive Pulmonary Disease
• Primary pulmonary hypertension

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (2)

Unknown Facility

Milan, Italy

Location

Unknown Facility

Rome, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Giovanni B Forleo, MD, PhD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

• Luca Santini, MD, PhD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

IT (2)