Arrhythmias Detection in a Real World Population

Official title

Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry

Overview

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).

Interventions

• Device implantable cardioverter defibrillator

Primary outcome measures

• Patients with ICD therapy (shock) [Time frame: 24 months]

Secondary outcome measures (4)

• Patients with inappropriate shock therapy [Time frame: 24 months]
• Incidence of ICD therapies [Time frame: 24 months]
• Time to first ICD therapy [Time frame: 24 months]
• Predictors of onset and Atrial Fibrillation (AF) burden [Time frame: 24 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 12 centers

• Ospedale Papa Giovanni XXIII — Bergamo
• Policlinico S.Orsola-Malpighi — Bologna
• P.O. Rodolico-San Marco — Catania
• Azienda Ospedaliero Universitaria Careggi — Florence
• ASST Rhodense- Ospedale di Rho — Milan
• IRCCS S.Ambrogio-Galeazzi — Milan
• Ospedale dei Colli Monaldi — Naples
• University of Padua — Padua
• … and 4 more centers

Publications

• 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 2 PMID 42190924
• 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 I PMID 40156599
• 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. Eu PMID 39834232
• 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):euad PMID 37656991
• 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. E PMID 37536671
• 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 PMID 37350404
• 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. d PMID 37278122
• 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;2 PMID 36932709

Identifiers

NCT: NCT02275637 · 20140002277 del 27/05/2014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗