NCT02275637

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2014Dec 2028

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 8, 2025

Status Verified

January 1, 2025

Enrollment Period

14.3 years

First QC Date

October 9, 2014

Last Update Submit

July 2, 2025

Conditions

Appropriate and Inappropriate Shock Therapy With ICDArrhythmias Detection

Keywords

Implantable Cardioverter-DefibrillatorsVentricular Fibrillationventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Patients with ICD therapy (shock)

    Clinical or instrumental parameters that could predict the appropriate ICD therapies

    24 months

Secondary Outcomes (4)

  • Patients with inappropriate shock therapy

    24 months

  • Incidence of ICD therapies

    24 months

  • Time to first ICD therapy

    24 months

  • Predictors of onset and Atrial Fibrillation (AF) burden

    24 months

Interventions

implantable cardioverter defibrillatorDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study requires patients implanted with a defibrillator that meet all inclusion/exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Ospedale Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Italy

RECRUITING

P.O. Rodolico-San Marco

Catania, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

ASST Rhodense- Ospedale di Rho

Milan, Italy

RECRUITING

IRCCS S.Ambrogio-Galeazzi

Milan, Italy

RECRUITING

Ospedale dei Colli Monaldi

Naples, Italy

RECRUITING

University of Padua

Padua, Italy

RECRUITING

IRCC Policlinico San Matteo

Pavia, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisa Cisanello

Pisa, Italy

RECRUITING

Azienda Ospedaliera S.Andrea

Rome, Italy

RECRUITING

Ospedale Bambino Gesù

Rome, Italy

RECRUITING

Related Publications (17)

  • 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.

    PMID: 40156599DERIVED

  • 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.

    PMID: 39834232DERIVED

  • 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.

    PMID: 37656991DERIVED

  • 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.

    PMID: 37536671DERIVED

  • 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.

    PMID: 37350404DERIVED

  • 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.

    PMID: 37278122DERIVED

  • 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.

    PMID: 36932709DERIVED

  • 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.

    PMID: 36881780DERIVED

  • 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.

    PMID: 36794691DERIVED

  • 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.

    PMID: 36266001DERIVED

  • 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.

    PMID: 34797012DERIVED

  • 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.

    PMID: 34395560DERIVED

  • 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.

    PMID: 34190592DERIVED

  • 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.

    PMID: 33969578DERIVED

  • 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.

    PMID: 33118017DERIVED

  • 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.

    PMID: 31778266DERIVED

  • 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.

    PMID: 31150817DERIVED

MeSH Terms

Conditions

Ventricular FibrillationTachycardia, Ventricular

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Central Study Contacts

Alessandro Vicentini, MD

CONTACT

0382.503715clinical-estimate@isis.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
EP and Pacing Laboratory Director

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 27, 2014

Study Start

September 1, 2014

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 8, 2025

Record last verified: 2025-01

Locations

IT(12)