Sudden Cardiac DeathELISIRNCT04373876
Experience From the Italian S-ICD Registry
An observational study of Sudden Cardiac Death and Cardiac Arrest, run by Luigi Sacco University Hospital at 18 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Cardiac Arrest, Ventricular Arrythmia
- What is being tested?
- Subcutaneous Implantable Cardioverter Defibrillator
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 1 Jan 2020to Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with S-ICD implanted for primary or secondary prevention of sudden cardiac death
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Italy15 sites, 15 recruiting
- Recruiting
Presidio Ospedaliero G. Salesi
Ancona, 60123
Antonio Dello Russo, MD, PhD, +390715961, antonio.dellorusso@gmail.com
- Recruiting
Presidio Ospedaliero Di Anzio e Nettuno
Anzio, Rome, 00042
Natale Di Belardino, MD, +390693271, natale.dibelardino@aslromah.it
- Recruiting
Policlinico Sant'Orsola-Malpighi
Bologna, 40138
Mauro Biffi, MD, +390512141111, mbiffi64@gmail.com
- Recruiting
Spedali Civili di Brescia
Brescia, 25123
Antonio Curnis, MD, +390303995552, antonio.curnis@unibs.it
- Recruiting
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Castrovillari, Cosenza, 87012
Giovanni Bisignani, MD, +3909814851, giovanni.bisignani@virgilio.it
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50139
Iacopo Olivotto, MD, +39055794111, iacopo.olivotto@unifi.it
- Recruiting
Ospedale Vito Fazzi
Lecce, 73100
Ennio Pisanò, MD, +390832661111, enniopisano@hotmail.com
- Recruiting
Presidio Ospedaliero G. B. Grassi
Lido di Ostia, Rome, 00122
Luca Santini, MD, +390656481, lsantini@alice.it
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, 20100
Claudio Tondo, MD, PhD, +3902580021, claudio.tondo@cardiologicomonzino.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Simone Gulletta, MD, +390226437484, simone.gulletta@hsr.it
- Recruiting
Ospedale Luigi Sacco - Polo Universitario
Milan, 20157
Giovanni B Forleo, MD, PhD, +390239042789, forleo@me.com
Marco Schiavone, MD
- Recruiting
Ospedale San Gerardo
Monza, 20900
Giovanni Rovaris, MD, +390392331, rovaris.gi@gmail.com
- Recruiting
Policlinico Universitario Campus Bio-Medico
Rome, 00128
Danilo Ricciardi, MD, +3906225411612, d.ricciardi@unicampus.it
Francesco Picarelli, MD
- Recruiting
Ospedale San Filippo Neri
Rome, 00135
Carlo Pignalberi, MD, +390633061, carlo.pignalberi@aslroma1.it
- Recruiting
Policlinico Umberto I
Rome, 00161
Carlo Lavalle, MD, +390649971, carlolavalle@yahoo.it
France1 site, 1 recruiting
- Recruiting
Pitié-Salpêtrière University Hospital
Paris, 75013
Nicolas Badenco, MD, +33142160000, nicolas.badenco@aphp.fr
Germany1 site, 1 recruiting
- Recruiting
Asklepios Klinik St. Georg
Hamburg, 20099
Lukas Kaiser, MD, +49401818850, lukaskaiser@kpmg.de
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zürich
Zurich, 8091
Alexander Breitenstein, MD, +41442551111, alexander.breitenstein@usz.ch
About this study
Official title: 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.
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.
- Conditions
- Sudden Cardiac Death, Cardiac Arrest, Ventricular Arrythmia, Implantable Cardiac Defibrillator
- Being tested
- Subcutaneous Implantable Cardioverter Defibrillator
- Medical subject headings
- Death, Sudden, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Implantable Cardioverter DefibrillatorDevice
Patients implanted with a totally subcutaneous defibrillator system
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall or arrhythmic mortality
Measured: 2 years
Appropriate shocks
Appropriate therapies delivered by the devices
Measured: 2 years
Inappropriate shocks
Inappropriate therapies delivered by the devices
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni B Forleo, Luigi Sacco University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373876
- Sponsor's protocol ID
- S-ICD-ITA
- Acronym
- ELISIR
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 35257974Forleo 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 34214647Ricciardi 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)
- ClinicalTrials.gov ID
- NCT04373876
- Acronym / sponsor ID
- ELISIR / S-ICD-ITA
- Conditions
- Sudden Cardiac Death, Cardiac Arrest, Ventricular Arrythmia, Implantable Cardiac Defibrillator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with S-ICD implanted for primary or secondary prevention of sudden cardiac death
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous Implantable Cardioverter DefibrillatorPatients implanted with a totally subcutaneous defibrillator system | Device | – |
Primary outcome
Mortality
Time frame: 2 years
Overall or arrhythmic mortality
Appropriate shocks
Time frame: 2 years
Appropriate therapies delivered by the devices
Inappropriate shocks
Time frame: 2 years
Inappropriate therapies delivered by the devices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 35257974Gulletta 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.
- Derived from this study: PubMed 34214647Forleo 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.
- Derived from this study: PubMed 33296533Ricciardi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Castrovillari, Italy
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Cardiac Arrest, run by Luigi Sacco University Hospital at 18 sites in 4 countries.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, France, Germany, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT04373876, which also lists 3 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 13 Apr 2021.