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The study is a prospective multicenter registry. Consecutive patients with indications of implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be enrolled.
The primary objective of the study is to determine the predictors of appropriate anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with an ICD.
Secondary objectives of the study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implantable cardioverter defibrillator | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with ICD therapy (shock) | Clinical or instrumental parameters that could predict the appropriate ICD therapies | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with inappropriate shock therapy | Clinical or instrumental parameters that could predict the inappropriate ICD therapies | 24 months |
| Incidence of ICD therapies | Number of patients with ICD therapies |
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Inclusion Criteria:
Exclusion Criteria:
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This study requires patients implanted with a defibrillator that meet all inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Vicentini, MD | Contact | 0382.503715 | 0039 | clinical-estimate@isis.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Papa Giovanni XXIII | Recruiting | Bergamo | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42190924 | Derived | Botto GL, Migliore F, Pieragnoli P, Viani S, Bisignani A, Ziacchi M, Silvetti MS, Nigro G, Bianchi V, Mariani MV, Savarese G, Pittorru R, Bambagioni G, Lovecchio M, Valsecchi S, Biffi M, Casale MC; "S-ICD Rhythm Detect" investigators. Subcutaneous ICD therapy in patients with monomorphic ventricular tachycardia: Arrhythmia recurrence, shock rate, and management strategies. Heart Rhythm. 2026 May 25:S1547-5271(26)02401-X. doi: 10.1016/j.hrthm.2026.05.034. Online ahead of print. | |
| 40156599 |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 24 months |
| Time to first ICD therapy | 24 months |
| Predictors of onset and Atrial Fibrillation (AF) burden | 24 months |
| Policlinico S.Orsola-Malpighi | Recruiting | Bologna | Italy |
|
| P.O. Rodolico-San Marco | Recruiting | Catania | Italy |
|
| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | Italy |
|
| ASST Rhodense- Ospedale di Rho | Recruiting | Milan | Italy |
|
| IRCCS S.Ambrogio-Galeazzi | Recruiting | Milan | Italy |
|
| Ospedale dei Colli Monaldi | Recruiting | Naples | Italy |
|
| University of Padua | Recruiting | Padua | Italy |
|
| IRCC Policlinico San Matteo | Recruiting | Pavia | Italy |
| Azienda Ospedaliero Universitaria Pisa Cisanello | Recruiting | Pisa | Italy |
|
| Azienda Ospedaliera S.Andrea | Recruiting | Rome | Italy |
|
| Ospedale Bambino Gesù | Recruiting | Rome | Italy |
|
| Derived |
| Migliore F, Ottaviano L, Arestia A, Nigro G, Dello Russo A, Viani S, Bianchi V, Bisignani A, Pieragnoli P, Vitulano G, Rordorf R, Francia P, Taravelli E, Pisano E, Lavalle C, Brambilla R, Ziacchi M, Rapacciuolo A, Viscusi M, De Filippo P, La Greca C, Pepi P, Notarstefano P, Curcio A, Pittorru R, Martini N, Seganti A, Napolitano C, Lovecchio M, Valsecchi S, Botto G, Priori SG; S-ICD Rhythm Detect Investigators. Subcutaneous Implantable Defibrillator Therapy in Patients With Brugada Syndrome: Data From a Large Multicenter Registry. JACC Clin Electrophysiol. 2025 Jul;11(7):1572-1582. doi: 10.1016/j.jacep.2025.03.003. Epub 2025 Mar 29. |
| 39834232 | Derived | Ziacchi M, Ottaviano L, Checchi L, Viani S, Nigro G, Bianchi V, De Bonis S, De Filippo P, Francia P, Rapacciuolo A, Vitulano G, Perego GB, Schillaci V, Lavalle C, Migliore F, Pisano ECL, Compagnucci P, Palmisano P, Botto G, Rordorf R, Lovecchio M, Valsecchi S, Biffi M. The risk of failure of subcutaneous implantable cardioverter defibrillator therapy: from PRAETORIAN score to clinical practice. Europace. 2025 Feb 5;27(2):euaf011. doi: 10.1093/europace/euaf011. |
| 37656991 | Derived | Boriani G, Bertini M, Manzo M, Calo L, Santini L, Savarese G, Dello Russo A, Santobuono VE, Lavalle C, Viscusi M, Amellone C, Calvanese R, Santoro A, Rapacciuolo A, Ziacchi M, Arena G, Imberti JF, Campari M, Valsecchi S, D'Onofrio A. Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation. Europace. 2023 Aug 2;25(9):euad261. doi: 10.1093/europace/euad261. |
| 37536671 | Derived | Migliore F, Biffi M, Viani S, Pittorru R, Francia P, Pieragnoli P, De Filippo P, Bisignani G, Nigro G, Dello Russo A, Pisano E, Palmisano P, Rapacciuolo A, Silvetti MS, Lavalle C, Curcio A, Rordorf R, Lovecchio M, Valsecchi S, D'Onofrio A, Botto GL. Modern subcutaneous implantable defibrillator therapy in patients with cardiomyopathies and channelopathies: data from a large multicentre registry. Europace. 2023 Aug 2;25(9):euad239. doi: 10.1093/europace/euad239. |
| 37350404 | Derived | De Filippo P, Migliore F, Palmisano P, Nigro G, Ziacchi M, Rordorf R, Pieragnoli P, Di Grazia A, Ottaviano L, Francia P, Pisano E, Tola G, Giammaria M, D'Onofrio A, Botto GL, Zucchelli G, Ferrari P, Lovecchio M, Valsecchi S, Viani S. Procedure, management, and outcome of subcutaneous implantable cardioverter-defibrillator extraction in clinical practice. Europace. 2023 Jun 2;25(6):euad158. doi: 10.1093/europace/euad158. |
| 37278122 | Derived | Santobuono VE, Favale S, D'Onofrio A, Manzo M, Calo L, Bertini M, Savarese G, Santini L, Dello Russo A, Lavalle C, Viscusi M, Amellone C, Calvanese R, Arena G, Pangallo A, Rapacciuolo A, Porcelli D, Campari M, Valsecchi S, Guaricci AI. Performance of a multisensor implantable defibrillator algorithm for heart failure monitoring related to co-morbidities. ESC Heart Fail. 2023 Aug;10(4):2469-2478. doi: 10.1002/ehf2.14416. Epub 2023 Jun 5. |
| 36932709 | Derived | Rordorf R, Viani S, Biffi M, Pieragnoli P, Migliore F, D'Onofrio A, Nigro G, Francia P, Ferrari P, Dello Russo A, Bisignani A, Ottaviano L, Palmisano P, Caravati F, Pisano E, Pani A, Botto GL, Lovecchio M, Valsecchi S, Vicentini A. Reduction in inappropriate therapies through device programming in subcutaneous implantable defibrillator patients: data from clinical practice. Europace. 2023 May 19;25(5):euac234. doi: 10.1093/europace/euac234. |
| 36881780 | Derived | Bertini M, Vitali F, D'Onofrio A, Vitulano G, Calo L, Savarese G, Santobuono VE, Dello Russo A, Mattera A, Santoro A, Calvanese R, Arena G, Amellone C, Ziacchi M, Palmisano P, Santini L, Mazza A, Campari M, Valsecchi S, Boriani G. Combination of an implantable defibrillator multi-sensor heart failure index and an apnea index for the prediction of atrial high-rate events. Europace. 2023 Apr 15;25(4):1467-1474. doi: 10.1093/europace/euad052. |
| 36794691 | Derived | Botto GL, Ziacchi M, Nigro G, D'Onofrio A, Dello Russo A, Francia P, Viani S, Pisano E, Bisignani G, Caravati F, Migliore F, De Filippo P, Ottaviano L, Rordorf R, Manzo M, Canevese FL, Lovecchio M, Valsecchi S, Checchi L. Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study. Europace. 2023 Apr 15;25(4):1423-1431. doi: 10.1093/europace/euad028. |
| 36266001 | Derived | Mazza A, Bendini MG, Bianchi V, Esposito C, Calo L, Andreoli C, Santobuono VE, Dello Russo A, Viscusi M, La Greca C, Baiocchi C, Talarico A, Albanese R, Arena G, Giubilato G, Ziacchi M, Rapacciuolo A, Campari M, Valsecchi S, Boriani G. Association Between Device-Detected Sleep-Disordered Breathing and Implantable Defibrillator Therapy in Patients With Heart Failure. JACC Clin Electrophysiol. 2022 Oct;8(10):1249-1256. doi: 10.1016/j.jacep.2022.07.017. Epub 2022 Sep 28. |
| 34797012 | Derived | Vicentini A, Bisignani G, De Vivo S, Viani S, Savarese G, Francia P, Celentano E, Checchi L, Carreras G, Santini L, Lamberti F, Ottaviano L, Scalone A, Giorgi D, Lovecchio M, Valsecchi S, Rordorf R; "S-ICD Rhythm Detect" Investigators. Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience. J Cardiovasc Electrophysiol. 2022 Jan;33(1):81-89. doi: 10.1111/jce.15297. Epub 2021 Nov 28. |
| 34395560 | Derived | Russo V, Viani S, Migliore F, Nigro G, Biffi M, Tola G, Bisignani G, Dello Russo A, Sartori P, Rordorf R, Ottaviano L, Perego GB, Checchi L, Segreti L, Bertaglia E, Lovecchio M, Valsecchi S, Bongiorni MG. Lead Abandonment and Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) Implantation in a Cohort of Patients With ICD Lead Malfunction. Front Cardiovasc Med. 2021 Jul 27;8:692943. doi: 10.3389/fcvm.2021.692943. eCollection 2021. |
| 34190592 | Derived | Calo L, Bianchi V, Ferraioli D, Santini L, Dello Russo A, Carriere C, Santobuono VE, Andreoli C, La Greca C, Arena G, Talarico A, Pisano E, Santoro A, Giammaria M, Ziacchi M, Viscusi M, De Ruvo E, Campari M, Valsecchi S, D'Onofrio A; Full list of participant centers and investigators. Multiparametric Implantable Cardioverter-Defibrillator Algorithm for Heart Failure Risk Stratification and Management: An Analysis in Clinical Practice. Circ Heart Fail. 2021 Oct;14(10):e008134. doi: 10.1161/CIRCHEARTFAILURE.120.008134. Epub 2021 Jun 30. |
| 33969578 | Derived | Francia P, Adduci C, Angeletti A, Ottaviano L, Perrotta L, De Vivo S, Bongiorni MG, Migliore F, Russo AD, De Filippo P, Caravati F, Nigro G, Palmisano P, Viani S, D'Onofrio A, Lovecchio M, Valsecchi S, Ziacchi M. Acute shock efficacy of the subcutaneous implantable cardioverter-defibrillator according to the implantation technique. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1695-1703. doi: 10.1111/jce.15081. Epub 2021 May 16. |
| 33118017 | Derived | Francia P, Biffi M, Adduci C, Ottaviano L, Migliore F, De Bonis S, Dello Russo A, De Filippo P, Viani S, Bongiorni MG, Caravati F, Lavalle C, Landolina ME, Pisano E, Giorgi D, Lovecchio M, Valsecchi S, Diemberger I. Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study. Europace. 2020 Dec 23;22(12):1822-1829. doi: 10.1093/europace/euaa231. |
| 31778266 | Derived | Ziacchi M, Bisignani G, Palmisano P, Scalone A, Martignani C, Elvira Mocavero P, Caravati F, Della Cioppa N, Mazzuero A, Pecora D, Vicentini A, Landolina ME, Debonis S, Scimia P, Lovecchio M, Valsecchi S, Diemberger I, Droghetti A. Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case-control analysis. J Cardiovasc Electrophysiol. 2020 Jan;31(1):144-149. doi: 10.1111/jce.14293. Epub 2019 Dec 3. |
| 31150817 | Derived | Diemberger I, Migliore F, Ricciardi G, Ottaviano L, Tavoletta V, Francia P, Viani S, Capucci A, de Filippo P, Nigro G, Caravati F, Palmisano P, Ziacchi M, Lovecchio M, Valsecchi S, Bongiorni MG, Biffi M; "S-ICD Rhythm Detect" Investigators. Time to therapy delivery and effectiveness of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2019 Oct;16(10):1531-1537. doi: 10.1016/j.hrthm.2019.05.028. Epub 2019 May 29. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |