Appropriate and Inappropriate Shock Therapy With ICDRHYTHM DETECTNCT02275637

Arrhythmias Detection in a Real World Population

An observational study of Appropriate and Inappropriate Shock Therapy With ICD and Arrhythmias Detection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 12 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Appropriate and Inappropriate Shock Therapy With ICD, Arrhythmias Detection
What is being tested?: implantable cardioverter defibrillator
Type of treatment: Medical device
How many people: 10,000 participants
Where: 12 sitesItaly
Study dates: Sep 2014to Dec 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alessandro Vicentini, MD contact

0382.503715 ext. 0039

clinical-estimate@isis.it

City, postcode or hospital

Sites recruiting now only

12 sites in 1 country

Italy12 sites, 12 recruiting

Ospedale Papa Giovanni XXIII
Bergamo
Paolo De Filippo, 035 267 3522 ext. 0039, pdefilippo@asst-pg23.it
Recruiting
Policlinico S.Orsola-Malpighi
Bologna
Mauro Biffi, 051 2143259 ext. 0039, mauro.biffi@aosp.bo.it
Recruiting
P.O. Rodolico-San Marco
Catania
Valeria Calvi, 095 3781172 ext. 0039, valcalvi@unict.it
Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence
Paolo Pieragnoli, 055 794111 ext. 0039, pieragnolip@aou-careggi.toscana.it
Recruiting
ASST Rhodense- Ospedale di Rho
Milan
Gianluca Botto, 02.994301 ext. 0039, gluca.botto@gmail.com
Recruiting
IRCCS S.Ambrogio-Galeazzi
Milan
Luca Ottaviano, 0224209619 ext. 0039, lucaottavianodr@gmail.com
Recruiting
Ospedale dei Colli Monaldi
Naples
Valter Bianchi, 081 578 7109 ext. 0039, Valterbianchi.59@gmail.com
Recruiting
University of Padua
Padua
Federico Migliore, 049 8212479 ext. 0039, federico.migliore@unipd.it
Recruiting
IRCC Policlinico San Matteo
Pavia
Recruiting
Azienda Ospedaliero Universitaria Pisa Cisanello
Pisa
Stefano Viani, 050 993043 ext. 0039, s.viani@ao-pisa.toscana.it
Recruiting
Azienda Ospedaliera S.Andrea
Rome
Pietro Francia, 06 33 77 55 61 ext. 0039, pietro.francia@uniroma1.it
Recruiting
Ospedale Bambino Gesù
Rome
Massimo Silvetti, 06.6859.3354 ext. 0039, mstefano.silvetti@opbg.net
Recruiting

Other trials in Italy

About this study

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

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).

Conditions: Appropriate and Inappropriate Shock Therapy With ICD, Arrhythmias Detection
Being tested: implantable cardioverter defibrillator
Keywords: Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, ventricular Tachycardia
Medical subject headings: Ventricular Fibrillation, Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

implantable cardioverter defibrillatorDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients with ICD therapy (shock)
Clinical or instrumental parameters that could predict the appropriate ICD therapies
Measured: 24 months

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2028

First posted27 Oct 2014 (estimated)
Study startSep 2014
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Appropriate and Inappropriate Shock Therapy With ICDStudies of the same condition, open and under way.
More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 10,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02275637
Sponsor's protocol ID: 20140002277 del 27/05/2014
Acronym: RHYTHM DETECT
Status last verified: Jan 2025
First submitted: 9 Oct 2014
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: No

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 25:S1547-5271(26)02401-X. doi: 10.1016/j.hrthm.2026.05.034. Online ahead of print.
PubMed 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 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.
PubMed 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. Europace. 2025 Feb 5;27(2):euaf011. doi: 10.1093/europace/euaf011.
PubMed 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):euad261. doi: 10.1093/europace/euad261.
PubMed 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. Europace. 2023 Aug 2;25(9):euad239. doi: 10.1093/europace/euad239.
PubMed 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: 10.1093/europace/euad158.
PubMed 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. doi: 10.1002/ehf2.14416. Epub 2023 Jun 5.
PubMed 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;25(5):euac234. doi: 10.1093/europace/euac234.
PubMed 36932709
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.
PubMed 36881780
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.
PubMed 36794691
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.
PubMed 36266001
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.
PubMed 34797012
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.
PubMed 34395560
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.
PubMed 34190592
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.
PubMed 33969578

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
ClinicalTrials.gov ID: NCT02275637
Acronym / sponsor ID: RHYTHM DETECT / 20140002277 del 27/05/2014
Conditions: Appropriate and Inappropriate Shock Therapy With ICD, Arrhythmias Detection
Keywords: Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, ventricular Tachycardia
Study type: Observational
Recruitment status: Recruiting
Enrolment: 10,000 participants (estimated)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
Study start: Sep 2014
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 27 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: This study requires patients implanted with a defibrillator that meet all inclusion/exclusion criteria.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
implantable cardioverter defibrillator	Device	–

Primary outcome

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

4 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Derived from this study: PubMed 42190924Botto 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.
Derived from this study: PubMed 40156599Migliore 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.
Derived from this study: PubMed 39834232Ziacchi 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.
Derived from this study: PubMed 37656991Boriani 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.
Derived from this study: PubMed 37536671Migliore 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.
Derived from this study: PubMed 37350404De 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.
Derived from this study: PubMed 37278122Santobuono 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.
Derived from this study: PubMed 36932709Rordorf 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.
Derived from this study: PubMed 36881780Bertini 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.
Derived from this study: PubMed 36794691Botto 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.
Derived from this study: PubMed 36266001Mazza 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.
Derived from this study: PubMed 34797012Vicentini 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Alessandro Vicentini, MD contact

0382.503715 ext. 0039

clinical-estimate@isis.it

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Appropriate and Inappropriate Shock Therapy With ICD and Arrhythmias Detection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alessandro Vicentini, MD (0382.503715 ext. 0039, clinical-estimate@isis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients with ICD therapy (shock) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275637, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.