Arrhythmias Detection in a Real World Population

Conditions

Appropriate and Inappropriate Shock Therapy With ICD, Arrhythmias Detection

Keywords

Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, ventricular Tachycardia

Brief summary

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).

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, Pisanò 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.

2025-03-292 citations

10.1016/j.jacep.2025.03.003

The risk of failure of subcutaneous implantable cardioverter defibrillator therapy: from PRAETORIAN score to clinical practice

Matteo Ziacchi, Luca Ottaviano, Luca Checchi, Stefano Viani, Gerardo Nigro et al. (23 authors)

EP Europace2025-01-214 citations

10.1093/europace/euaf011

Modern subcutaneous implantable defibrillator therapy in patients with cardiomyopathies and channelopathies: data from a large multicentre registry

Federico Migliore, Mauro Biffi, Stefano Viani, Raimondo Pittorru, Pietro Francia et al. (21 authors)

EP Europace2023-08-0218 citations

10.1093/europace/euad239

Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation

Giuseppe Boriani, Matteo Bertini, Michele Manzo, Leonardo Calò, Luca Santini et al. (20 authors)

EP Europace2023-08-027 citations

10.1093/europace/euad261

Procedure, management, and outcome of subcutaneous implantable cardioverter–defibrillator extraction in clinical practice

Paolo De Filippo, Federico Migliore, Pietro Palmisano, Gerardo Nigro, Matteo Ziacchi et al. (20 authors)

EP Europace2023-06-0113 citations

10.1093/europace/euad158

Reduction in inappropriate therapies through device programming in subcutaneous implantable defibrillator patients: data from clinical practice

Roberto Rordorf, Stefano Viani, Mauro Biffi, Paolo Pieragnoli, Federico Migliore et al. (20 authors)

EP Europace2023-03-1814 citations

10.1093/europace/euac234

Combination of an implantable defibrillator multi-sensor heart failure index and an apnea index for the prediction of atrial high-rate events

Matteo Bertini, Francesco Vitali, Antonio D’Onofrio, Gennaro Vitulano, Leonardo Calò et al. (20 authors)

EP Europace2023-03-073 citations

10.1093/europace/euad052

Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study

Giovanni Luca Botto, Matteo Ziacchi, Gerardo Nigro, Antonio D’Onofrio, Antonio Dello Russo et al. (19 authors)

EP Europace2023-02-1621 citations

10.1093/europace/euad028

Association Between Device-Detected Sleep-Disordered Breathing and Implantable Defibrillator Therapy in Patients With Heart Failure.

Mazza A, Bendini MG, Bianchi V, Esposito C, Calò 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.

2022-09-282 citations

10.1016/j.jacep.2022.07.017

Lead Abandonment and Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) Implantation in a Cohort of Patients With ICD Lead Malfunction

Vincenzo Russo, Stefano Viani, Federico Migliore, Gerardo Nigro, Mauro Biffi et al. (18 authors)

Frontiers in Cardiovascular Medicine2021-07-2712 citations

10.3389/fcvm.2021.692943

Multiparametric Implantable Cardioverter-Defibrillator Algorithm for Heart Failure Risk Stratification and Management: An Analysis in Clinical Practice

Leonardo Calò, Valter Bianchi, Donatella Ferraioli, Luca Santini, Antonio Dello Russo et al. (61 authors)

Circulation Heart Failure2021-06-3046 citations

10.1161/circheartfailure.120.008134

Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study

Pietro Francia, Mauro Biffi, Carmen Adduci, Luca Ottaviano, Federico Migliore et al. (18 authors)

EP Europace2020-07-1641 citations

10.1093/europace/euaa231

Interventions

DEVICEimplantable cardioverter defibrillator

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Patients with ICD therapy (shock)	24 months	Clinical or instrumental parameters that could predict the appropriate ICD therapies

Secondary

Measure	Time frame	Description
Patients with inappropriate shock therapy	24 months	Clinical or instrumental parameters that could predict the inappropriate ICD therapies
Incidence of ICD therapies	24 months	Number of patients with ICD therapies
Time to first ICD therapy	24 months	—
Predictors of onset and Atrial Fibrillation (AF) burden	24 months	—

Countries

Italy

Contacts

Primary ContactAlessandro Vicentini, MD

clinical-estimate@isis.it0382.503715

Outcome results

None listed