Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
10000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-09-30
Study Completion Date
2028-12-31
Brief Summary
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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:
* the incidence of anti-tachycardia therapies;
* the predictors of inappropriate therapy and onset of arrhythmia burden;
* the adherence to the current guidelines in the Italian clinical practice;
* the predictors of heart failure (HF) onset and response to cardiac resynchronization therapy (CRT).
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:
* the incidence of anti-tachycardia therapies;
* the predictors of inappropriate therapy and onset of arrhythmia burden;
* the adherence to the current guidelines in the Italian clinical practice;
* the predictors of heart failure (HF) onset and response to cardiac resynchronization therapy (CRT).
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Detailed Description
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Conditions
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Appropriate and Inappropriate Shock Therapy With ICD
Arrhythmias Detection
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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implantable cardioverter defibrillator
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patient implanted with a Subcutaneous (S)- Ventricular Chamber (VR)- Dual Chamber (DR) - or Cardiac Resynchronization Therapy (CRT) Defibrillator (this study will utilize all the market released CRT-D or VR/DR-ICD systems and leads)
* Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
* Patient must be able to attend all required follow-up visits at the study center for at least 12 months
* Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
* Patient must be able to attend all required follow-up visits at the study center for at least 12 months
Exclusion Criteria
* Patient is participating in another clinical study that may have an impact on the study endpoints
* Women who are pregnant or plan to become pregnant
* Women who are pregnant or plan to become pregnant
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Sponsor Role
lead
Responsible Party
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Maurizio Eugenio Landolina
EP and Pacing Laboratory Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Ospedale Papa Giovanni XXIII
Bergamo, , Italy
Site Status
RECRUITING
Policlinico S.Orsola-Malpighi
Bologna, , Italy
Site Status
RECRUITING
P.O. Rodolico-San Marco
Catania, , Italy
Site Status
RECRUITING
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Site Status
RECRUITING
ASST Rhodense- Ospedale di Rho
Milan, , Italy
Site Status
RECRUITING
IRCCS S.Ambrogio-Galeazzi
Milan, , Italy
Site Status
RECRUITING
Ospedale dei Colli Monaldi
Naples, , Italy
Site Status
RECRUITING
University of Padua
Padua, , Italy
Site Status
RECRUITING
IRCC Policlinico San Matteo
Pavia, , Italy
Site Status
RECRUITING
Azienda Ospedaliero Universitaria Pisa Cisanello
Pisa, , Italy
Site Status
RECRUITING
Azienda Ospedaliera S.Andrea
Rome, , Italy
Site Status
RECRUITING
Ospedale Bambino Gesù
Rome, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
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20140002277 del 27/05/2014
Identifier Type: -
Identifier Source: org_study_id
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