Experience From the Italian S-ICD Registry (ELISIR)

Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Ventricular Arrythmia; Sudden Cardiac Death; Implantable Cardiac Defibrillator
• Intervention / Treatment: Device: Subcutaneous Implantable Cardioverter Defibrillator

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Pitié-Salpêtrière University Hospital
    • Contact: Nicolas Badenco, MD; Phone Number: +33142160000; Email: nicolas.badenco@aphp.fr
• Germany
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinik St. Georg
    • Contact: Lukas Kaiser, MD; Phone Number: +49401818850; Email: lukaskaiser@kpmg.de
• Italy
  • Ancona, Italy, 60123
    • Recruiting
    • Presidio Ospedaliero G. Salesi
    • Contact: Antonio Dello Russo, MD, PhD; Phone Number: +390715961; Email: antonio.dellorusso@gmail.com
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sant'Orsola-Malpighi
    • Contact: Mauro Biffi, MD; Phone Number: +390512141111; Email: mbiffi64@gmail.com
  • Brescia, Italy, 25123
    • Recruiting
    • Spedali Civili di Brescia
  • Firenze, Italy, 50139
    • Recruiting
    • Azienda Ospedaliero-Universitaria Careggi
    • Contact: Iacopo Olivotto, MD; Phone Number: +39055794111; Email: iacopo.olivotto@unifi.it
  • Lecce, Italy, 73100
    • Recruiting
    • Ospedale Vito Fazzi
    • Contact: Ennio Pisanò, MD; Phone Number: +390832661111; Email: enniopisano@hotmail.com
  • Milan, Italy, 20132
    • Recruiting
    • Irccs Ospedale San Raffaele
    • Contact: Simone Gulletta, MD; Phone Number: +390226437484; Email: simone.gulletta@hsr.it
  • Milan, Italy, 20100
    • Recruiting
    • Centro Cardiologico Monzino, IRCCS
    • Contact: Claudio Tondo, MD, PhD; Phone Number: +3902580021; Email: claudio.tondo@cardiologicomonzino.it
  • Milan, Italy, 20157
    • Recruiting
    • Ospedale Luigi Sacco - Polo Universitario
    • Contact: Giovanni B Forleo, MD, PhD; Phone Number: +390239042789; Email: forleo@me.com
  • Monza, Italy, 20900
    • Recruiting
    • Ospedale San Gerardo
    • Contact: Giovanni Rovaris, MD; Phone Number: +390392331; Email: rovaris.gi@gmail.com
  • Rome, Italy, 00161
    • Recruiting
    • Policlinico Umberto I
    • Contact: Carlo Lavalle, MD; Phone Number: +390649971; Email: carlolavalle@yahoo.it
  • Rome, Italy, 00128
    • Recruiting
    • Policlinico Universitario Campus Bio-Medico
    • Contact: Danilo Ricciardi, MD; Phone Number: +3906225411612; Email: d.ricciardi@unicampus.it
    • Sub-Investigator: Francesco Picarelli, MD
  • Rome, Italy, 00135
    • Recruiting
    • Ospedale San Filippo Neri
    • Contact: Carlo Pignalberi, MD; Phone Number: +390633061; Email: carlo.pignalberi@aslroma1.it
  • Cosenza
    • Castrovillari, Cosenza, Italy, 87012
      • Recruiting
      • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
      • Contact: Giovanni Bisignani, MD; Phone Number: +3909814851; Email: giovanni.bisignani@virgilio.it
  • Rome
    • Anzio, Rome, Italy, 00042
      • Recruiting
      • Presidio Ospedaliero Di Anzio e Nettuno
      • Contact: Natale Di Belardino, MD; Phone Number: +390693271; Email: natale.dibelardino@aslromah.it
    • Lido Di Ostia, Rome, Italy, 00122
      • Recruiting
      • Presidio Ospedaliero G. B. Grassi
      • Contact: Luca Santini, MD; Phone Number: +390656481; Email: lsantini@alice.it
• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • University Hospital of Zürich
    • Contact: Alexander Breitenstein, MD; Phone Number: +41442551111; Email: alexander.breitenstein@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Overall or arrhythmic mortality	2 years
Appropriate shocks	Appropriate therapies delivered by the devices	2 years
Inappropriate shocks	Inappropriate therapies delivered by the devices	2 years

Collaborators and Investigators

• Sponsor: Luigi Sacco University Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: S-ICD-ITA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No