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Complication of Cardiac DefibrillatorTARIFFNCT01075516

Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients

An observational study of Complication of Cardiac Defibrillator, run by Abbott Medical Devices at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complication of Cardiac Defibrillator
How many people
209 participants
Where
6 sitesItaly
Study dates
Dec 2009to Apr 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters

Who may be able to join

  • Patients already implanted with ICD
  • Patients able to be followed in the same centre during all the study
  • Patients with age > 18
  • Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire

Who cannot join

  • Patients pregnant
  • Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Ospedale Careggi

    Florence

  • Ospedale Luigi Sacco

    Milan

  • Azienda Ospedaliera S.Gerardo

    Monza, Monza (MB), 20052

  • Ospedale Monaldi

    Naples

  • Casa di Cura Pederzoli

    Peschiera del Garda, VR

  • Ospedale San Filippo Neri

    Roma, 00135

Other trials in Italy

About this study

Official title: TARIFF Health Economics Evaluation Registry for Remote Follow up

The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.

Read the detailed description

TARIFF is a prospective observational study aimed to measure direct, indirect costs and quality of life of all participants for the duration of the observational timeframe. Purpose of cost collecting is to include a complete set of medical services and productivity loses that could be directly affected by the different clinical Follow-Up (FU) pathway. The study consists of 2 phases: firstly standard follow up costs will be collected for 100 pts, then all costs associated to remote follow ups will be collected for other 100 patients.

Keywords
Remote Monitoring, ICD patients, EQ-5D questionnaire, remote follow up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01075516
Study groupRoleWhat they receive
Standard Follow UpICD patients followed through periodic in-hospital visits
Remote Follow UpICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Economic Impact of Remote Monitoring on Hospitals and Patients

    Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.

    Measured: 12 months follow-up

Secondary outcomes (2)

  1. Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)

    Comparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up

    Measured: 1 year

  2. Impact of Remote Monitoring on Patients' Quality of Life

    Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system.

    Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes.

    One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).

    Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01075516
Sponsor's protocol ID
CR 09 021 IT RC
Acronym
TARIFF
Status last verified
Mar 2021
First submitted
2 Feb 2010
Last updated
3 Mar 2021
Data monitoring committee
No

Publications

  • Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008 Jun;5(6):907-25. doi: 10.1016/j.hrthm.2008.04.013. No abstract available.

    PubMed 18551743

  • Morichelli L, Ricci RP. Remote monitoring of implantable devices: the European experience. Heart Rhythm. 2009 Jul;6(7):1077-80. doi: 10.1016/j.hrthm.2009.02.030. Epub 2009 Feb 24. No abstract available.

    PubMed 19560096

  • Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009 Jan;11(1):54-61. doi: 10.1093/europace/eun303. Epub 2008 Nov 16.

    PubMed 19011260

  • Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.

    PubMed 18811805

  • Ricci RP, Morichelli L, Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace. 2008 Feb;10(2):164-70. doi: 10.1093/europace/eum289. Epub 2008 Jan 16.

    PubMed 18199570

  • Seto E. Cost comparison between telemonitoring and usual care of heart failure: a systematic review. Telemed J E Health. 2008 Sep;14(7):679-86. doi: 10.1089/tmj.2007.0114.

    PubMed 18817497

  • Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.

    PubMed 17426062

  • Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S; InSync ICD Italian Registry Investigators. Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry. Pacing Clin Electrophysiol. 2008 Jan;31(1):38-46. doi: 10.1111/j.1540-8159.2007.00923.x.

    PubMed 18181908

  • Ricci RP, D'Onofrio A, Padeletti L, Sagone A, Vicentini A, Vincenti A, Morichelli L, Cavallaro C, Ricciardi G, Lombardi L, Fusco A, Rovaris G, Silvestri P, Guidotto T, Pollastrelli A, Santini M. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012 Nov;14(11):1661-5. doi: 10.1093/europace/eus093. Epub 2012 Apr 27.

    PubMed 22544910

  • Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Vincenti A, Padeletti L, Morichelli L, Fusco A, Vecchione F, Lo Presti F, Denaro A, Pollastrelli A, Santini M. Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population. J Interv Card Electrophysiol. 2013 Nov;38(2):101-6. doi: 10.1007/s10840-013-9823-5. Epub 2013 Sep 21.

    PubMed 24057266

  • Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Rovaris G, Padeletti L, Morichelli L, Fusco A, De Vivo S, Lombardi L, Denaro A, Pollastrelli A, Colangelo I, Santini M. Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study. Heart Rhythm. 2017 Jan;14(1):50-57. doi: 10.1016/j.hrthm.2016.09.008. Epub 2016 Sep 8.

    PubMed 27614025

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Cardiac Defibrillator, run by Abbott Medical Devices at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Economic Impact of Remote Monitoring on Hospitals and Patients (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075516, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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