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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous Implantable Cardioverter Defibrillator | Device | Patients implanted with a totally subcutaneous defibrillator system |
| 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 |
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Inclusion Criteria:
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Patients with S-ICD implanted for primary or secondary prevention of sudden cardiac death
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié-Salpêtrière University Hospital | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257974 | Derived | 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. | |
| 34214647 |
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| Asklepios Klinik St. Georg | Recruiting | Hamburg | 20099 | Germany |
|
| Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari" | Recruiting | Castrovillari | Cosenza | 87012 | Italy |
|
| Presidio Ospedaliero Di Anzio e Nettuno | Recruiting | Anzio | Rome | 00042 | Italy |
|
| Presidio Ospedaliero G. B. Grassi | Recruiting | Lido di Ostia | Rome | 00122 | Italy |
|
| Presidio Ospedaliero G. Salesi | Recruiting | Ancona | 60123 | Italy |
|
| Policlinico Sant'Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
|
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Azienda Ospedaliero-Universitaria Careggi | Recruiting | Florence | 50139 | Italy |
|
| Ospedale Vito Fazzi | Recruiting | Lecce | 73100 | Italy |
|
| Centro Cardiologico Monzino, IRCCS | Recruiting | Milan | 20100 | Italy |
|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
|
| Ospedale Luigi Sacco - Polo Universitario | Recruiting | Milan | 20157 | Italy |
|
| Ospedale San Gerardo | Recruiting | Monza | 20900 | Italy |
|
| Policlinico Universitario Campus Bio-Medico | Recruiting | Rome | 00128 | Italy |
|
| Ospedale San Filippo Neri | Recruiting | Rome | 00135 | Italy |
|
| Policlinico Umberto I | Recruiting | Rome | 00161 | Italy |
|
| University Hospital of Zürich | Recruiting | Zurich | 8091 | Switzerland |
|
| Derived |
| 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. |
| 33296533 | Derived | 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. |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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