NCT04373876

Brief Summary

The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
4 countries

18 active sites

Status
unknown

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 Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

April 30, 2020

Last Update Submit

April 10, 2021

Conditions

Sudden Cardiac DeathCardiac ArrestVentricular ArrythmiaImplantable Cardiac Defibrillator

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Overall or arrhythmic mortality

    2 years

  • Appropriate shocks

    Appropriate therapies delivered by the devices

    2 years

  • Inappropriate shocks

    Inappropriate therapies delivered by the devices

    2 years

Interventions

Subcutaneous Implantable Cardioverter DefibrillatorDEVICE

Patients implanted with a totally subcutaneous defibrillator system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with S-ICD implanted for primary or secondary prevention of sudden cardiac death

You may qualify if:

  • Age \>/= 18 years
  • Patients successfully implanted with S-ICD
  • Patients able to provide written informed consent or have informed consent as provided by a legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Pitié-Salpêtrière University Hospital

Paris, 75013, France

RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

RECRUITING

Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

Castrovillari, Cosenza, 87012, Italy

RECRUITING

Presidio Ospedaliero Di Anzio e Nettuno

Anzio, Rome, 00042, Italy

RECRUITING

Presidio Ospedaliero G. B. Grassi

Lido di Ostia, Rome, 00122, Italy

RECRUITING

Presidio Ospedaliero G. Salesi

Ancona, 60123, Italy

RECRUITING

Policlinico Sant'Orsola-Malpighi

Bologna, 40138, Italy

RECRUITING

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50139, Italy

RECRUITING

Ospedale Vito Fazzi

Lecce, 73100, Italy

RECRUITING

Centro Cardiologico Monzino, IRCCS

Milan, 20100, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Ospedale Luigi Sacco - Polo Universitario

Milan, 20157, Italy

RECRUITING

Ospedale San Gerardo

Monza, 20900, Italy

RECRUITING

Policlinico Universitario Campus Bio-Medico

Rome, 00128, Italy

RECRUITING

Ospedale San Filippo Neri

Rome, 00135, Italy

RECRUITING

Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

University Hospital of Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (3)

  • Gulletta S, Gasperetti A, Schiavone M, Vogler J, Fastenrath F, Breitenstein A, Laredo M, Palmisano P, Mitacchione G, Compagnucci P, Kaiser L, Hakmi S, Angeletti A, De Bonis S, Picarelli F, Arosio R, Casella M, Steffel J, Fierro N, Guarracini F, Santini L, Pignalberi C, Piro A, Lavalle C, Pisano E, Viecca M, Curnis A, Badenco N, Ricciardi D, Dello Russo A, Tondo C, Kuschyk J, Della Bella P, Biffi M, Forleo GB, Tilz R. Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry. Heart Rhythm. 2022 Jul;19(7):1109-1115. doi: 10.1016/j.hrthm.2022.02.029. Epub 2022 Mar 5.

    PMID: 35257974DERIVED

  • Forleo GB, Gasperetti A, Breitenstein A, Laredo M, Schiavone M, Ziacchi M, Vogler J, Ricciardi D, Palmisano P, Piro A, Compagnucci P, Waintraub X, Mitacchione G, Carrassa G, Russo G, De Bonis S, Angeletti A, Bisignani A, Picarelli F, Casella M, Bressi E, Rovaris G, Calo L, Santini L, Pignalberi C, Lavalle C, Viecca M, Pisano E, Olivotto I, Curnis A, Dello Russo A, Tondo C, Love CJ, Di Biase L, Steffel J, Tilz R, Badenco N, Biffi M. Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study. Heart Rhythm. 2021 Dec;18(12):2072-2079. doi: 10.1016/j.hrthm.2021.06.1201. Epub 2021 Jun 30.

    PMID: 34214647DERIVED

  • Ricciardi D, Ziacchi M, Gasperetti A, Schiavone M, Picarelli F, Diemberger I, Bontempi L, Di Belardino N, Bisignani G, De Bonis S, Mitacchione G, Calabrese V, Lavalle C, Piro A, Pignalberi C, Santini L, Grigioni F, Tondo C, Biffi M, Forleo GB. Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry. J Cardiovasc Electrophysiol. 2021 Feb;32(2):468-476. doi: 10.1111/jce.14833. Epub 2020 Dec 18.

    PMID: 33296533DERIVED

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section head electrophysiology and cardiac pacing

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

IT(15)FR(1)DE(1)CH(1)