Clinical trial NCT04373876: Experience From the Italian S-ICD Registry
Official title: Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Cardiac Death
Cardiac Arrest
Ventricular Arrythmia
Implantable Cardiac Defibrillator
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with S-ICD implanted for primary or secondary prevention of sudden cardiac death

Brief 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.

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.

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

Primary outcomes:
measure: Mortality
timeFrame: 2 years
measure: Appropriate shocks
timeFrame: 2 years
measure: Inappropriate shocks
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière University Hospital
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Castrovillari
country: Italy
facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
state: Cosenza
city: Anzio
country: Italy
facility: Presidio Ospedaliero Di Anzio e Nettuno
state: Rome
city: Lido Di Ostia
country: Italy
facility: Presidio Ospedaliero G. B. Grassi
state: Rome
city: Ancona
country: Italy
facility: Presidio Ospedaliero G. Salesi
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: Ospedale Luigi Sacco - Polo Universitario
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Rome
country: Italy
facility: Ospedale San Filippo Neri
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Zürich
country: Switzerland
facility: University Hospital of Zürich
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.