External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators

NCT02147340 | Unknown

• 1 other identifier: 20130004180 del 24/09/2013
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to describe the use of Remote Patient Management (RPM) systems equipped with sensors for the measurement of weight and blood pressure in an Italian health care setting, verifying their efficacy and efficiency for the remote management of heart failure patients with implantable defibrillators. Moreover, their ease of use and acceptance by physician and patient will be assessed.

Conditions

Congestive Heart Failure

Keywords

Heart Failure patients; Remote Patient Management; External Sensors

Outcome Measures

Primary Outcomes (1)

• Number of planned and unplanned admissions

  All planned and unplanned hospital and Emergency Department (ED) admissions (not involving an overnight stay) All planned and unplanned hospitalizations (involving an overnight stay or resulting in death)

  16 months

Secondary Outcomes (2)

• The number of all cardiac or device related ED visits

  16 months

• The number of all unplanned cardiac or device related clinic/urgent visits

  16 months

Study Arms (1)

Heart failure patients with ICD

Heart failure patients with ICD and RPM system equipped with sensors for the measurement of weight and pressure

Eligibility Criteria

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

Study Population

All Heart failure patients implanted with cardiac Resynchronization therapy-defibrillator (CRT-D) or ICD (mono-VR- or dual chamber-DR) will receive an RPM system equipped with sensors for the measurement of weight and pressure for remote management.

You may qualify if:

• Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤ 35%, as documented at the moment of device implant.
• Patient implanted with a Cardiac Resynchronization Therapy-Defibrillator (CRT-D) or implantable defibrillator (ICD) device.
• Patient must be able and willing to replace regularly-scheduled in-office routine follow-ups with remote follow-ups.
• Patient must be able to attend all required follow-up visits at the study center.

You may not qualify if:

• Patient is less than 18 years of age.
• Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
• Patient life expectancy is less than 12 months.
• Patient is participating in another clinical study that may have an impact on the study endpoints.

Sponsors & Collaborators

• Maurizio Eugenio Landolina: lead

Study Sites (1)

Policlinico San Matteo

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maurizio Eugenio Landolina

  Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Eugenio Landolina

CONTACT

clinical-estimate@isis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Pacing and EP lab Policinico San Matteo

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

IT (1)