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Status unknownNCT04373876ELISIRUpdated Apr 13, 2021

Experience From the Italian S-ICD Registry

An observational study in Sudden Cardiac Death, Cardiac Arrest and Ventricular Arrythmia, sponsored by Luigi Sacco University Hospital. Status unknown at 18 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-13.

Sponsored by Luigi Sacco University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

Read the detailed description

ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD).

A number of about 10 enrolling centers is estimated with an overall number of 400 patients.

A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.

02

Conditions studied

  • Sudden Cardiac Death
  • Cardiac Arrest
  • Ventricular Arrythmia
  • Implantable Cardiac Defibrillator
03

In context

Death, Sudden, Cardiac

314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.

This study's planned enrollment of 500 is close to the median of 500 across 172 observational studies indexed under Death, Sudden, Cardiac.

Browse Death, Sudden, Cardiac studies →

Lead sponsor

Luigi Sacco University Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with S-ICD implanted for primary or secondary prevention of sudden cardiac death

Eligibility criteria

Inclusion Criteria:

  • Age >/= 18 years
  • Patients successfully implanted with S-ICD
  • Patients able to provide written informed consent or have informed consent as provided by a legal representative
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DeviceSubcutaneous Implantable Cardioverter Defibrillator

    Patients implanted with a totally subcutaneous defibrillator system

06

What researchers measure

Primary outcomes

  1. Mortality

    Overall or arrhythmic mortality

    Time frame: 2 years

  2. Appropriate shocks

    Appropriate therapies delivered by the devices

    Time frame: 2 years

  3. Inappropriate shocks

    Inappropriate therapies delivered by the devices

    Time frame: 2 years

07

Study locations

18 of 18 sites recruiting
  • Pitié-Salpêtrière University Hospital
    Paris, 75013, France
    Recruiting
  • Asklepios Klinik St. Georg
    Hamburg, 20099, Germany
    Recruiting
  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
    Castrovillari, Cosenza 87012, Italy
    Recruiting
  • Presidio Ospedaliero Di Anzio e Nettuno
    Anzio, Rome 00042, Italy
    Recruiting
  • Presidio Ospedaliero G. B. Grassi
    Lido Di Ostia, Rome 00122, Italy
    Recruiting
  • Presidio Ospedaliero G. Salesi
    Ancona, 60123, Italy
    Recruiting
  • Policlinico Sant'Orsola-Malpighi
    Bologna, 40138, Italy
    Recruiting
  • Spedali Civili di Brescia
    Brescia, 25123, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Careggi
    Firenze, 50139, Italy
    Recruiting
  • Ospedale Vito Fazzi
    Lecce, 73100, Italy
    Recruiting
  • Centro Cardiologico Monzino, IRCCS
    Milan, 20100, Italy
    Recruiting
  • IRCCS Ospedale San Raffaele
    Milan, 20132, Italy
    Recruiting
  • Ospedale Luigi Sacco - Polo Universitario
    Milan, 20157, Italy
    • Giovanni B Forleo, MD, PhD · Contact · forleo@me.com · +390239042789
    • Marco Schiavone, MD · Sub investigator
    • Alessio Gasperetti, MD · Sub investigator
    • Gianfranco Mitacchione, MD, PhD · Sub investigator
    Recruiting
  • Ospedale San Gerardo
    Monza, 20900, Italy
    Recruiting
  • Policlinico Universitario Campus Bio-Medico
    Rome, 00128, Italy
    • Danilo Ricciardi, MD · Contact · d.ricciardi@unicampus.it · +3906225411612
    • Francesco Picarelli, MD · Sub investigator
    Recruiting
  • Ospedale San Filippo Neri
    Rome, 00135, Italy
    Recruiting
  • Policlinico Umberto I
    Rome, 00161, Italy
    Recruiting
  • University Hospital of Zürich
    Zürich, 8091, Switzerland
    Recruiting
08

References and documents

Publications

  • Gulletta S, Gasperetti A, Schiavone M, Vogler J, Fastenrath F, Breitenstein A, Laredo M, Palmisano P, Mitacchione G, Compagnucci P, Kaiser L, Hakmi S, Angeletti A, De Bonis S, Picarelli F, Arosio R, Casella M, Steffel J, Fierro N, Guarracini F, Santini L, Pignalberi C, Piro A, Lavalle C, Pisano E, Viecca M, Curnis A, Badenco N, Ricciardi D, Dello Russo A, Tondo C, Kuschyk J, Della Bella P, Biffi M, Forleo GB, Tilz R. Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry. Heart Rhythm. 2022 Jul;19(7):1109-1115. doi: 10.1016/j.hrthm.2022.02.029. Epub 2022 Mar 5. PubMed 35257974 ↗
  • Forleo GB, Gasperetti A, Breitenstein A, Laredo M, Schiavone M, Ziacchi M, Vogler J, Ricciardi D, Palmisano P, Piro A, Compagnucci P, Waintraub X, Mitacchione G, Carrassa G, Russo G, De Bonis S, Angeletti A, Bisignani A, Picarelli F, Casella M, Bressi E, Rovaris G, Calo L, Santini L, Pignalberi C, Lavalle C, Viecca M, Pisano E, Olivotto I, Curnis A, Dello Russo A, Tondo C, Love CJ, Di Biase L, Steffel J, Tilz R, Badenco N, Biffi M. Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study. Heart Rhythm. 2021 Dec;18(12):2072-2079. doi: 10.1016/j.hrthm.2021.06.1201. Epub 2021 Jun 30. PubMed 34214647 ↗
  • Ricciardi D, Ziacchi M, Gasperetti A, Schiavone M, Picarelli F, Diemberger I, Bontempi L, Di Belardino N, Bisignani G, De Bonis S, Mitacchione G, Calabrese V, Lavalle C, Piro A, Pignalberi C, Santini L, Grigioni F, Tondo C, Biffi M, Forleo GB. Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry. J Cardiovasc Electrophysiol. 2021 Feb;32(2):468-476. doi: 10.1111/jce.14833. Epub 2020 Dec 18. PubMed 33296533 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04373876
Lead sponsor
Luigi Sacco University Hospital
Responsible party
Giovanni B Forleo (Section head electrophysiology and cardiac pacing, Luigi Sacco University Hospital) — Principal investigator
First posted
May 5, 2020
Start date
Jan 1, 2020
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Apr 13, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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