ELISIR: Experience From the Italian S-ICD Registry

Sponsor

Luigi Sacco University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04373876

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

27.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Cardiac Death Cardiac Arrest Ventricular Arrythmia Implantable Cardiac Defibrillator	Device: Subcutaneous Implantable Cardioverter Defibrillator

Detailed Description

ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD).

A number of about 10 enrolling centers is estimated with an overall number of 400 patients.

A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Mortality [2 years]
Overall or arrhythmic mortality
Appropriate shocks [2 years]
Appropriate therapies delivered by the devices
Inappropriate shocks [2 years]
Inappropriate therapies delivered by the devices

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pitié-Salpêtrière University Hospital	Paris		France	75013
2	Asklepios Klinik St. Georg	Hamburg		Germany	20099
3	Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"	Castrovillari	Cosenza	Italy	87012
4	Presidio Ospedaliero Di Anzio e Nettuno	Anzio	Rome	Italy	00042
5	Presidio Ospedaliero G. B. Grassi	Lido Di Ostia	Rome	Italy	00122
6	Presidio Ospedaliero G. Salesi	Ancona		Italy	60123
7	Policlinico Sant'Orsola-Malpighi	Bologna		Italy	40138
8	Spedali Civili di Brescia	Brescia		Italy	25123
9	Azienda Ospedaliero-Universitaria Careggi	Firenze		Italy	50139
10	Ospedale Vito Fazzi	Lecce		Italy	73100
11	Centro Cardiologico Monzino, IRCCS	Milan		Italy	20100
12	IRCCS Ospedale San Raffaele	Milan		Italy	20132
13	Ospedale Luigi Sacco - Polo Universitario	Milan		Italy	20157
14	Ospedale San Gerardo	Monza		Italy	20900
15	Policlinico Universitario Campus Bio-Medico	Rome		Italy	00128
16	Ospedale San Filippo Neri	Rome		Italy	00135
17	Policlinico Umberto I	Rome		Italy	00161
18	University Hospital of Zürich	Zürich		Switzerland	8091

Sponsors and Collaborators

Luigi Sacco University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giovanni B Forleo, Section head electrophysiology and cardiac pacing, Luigi Sacco University Hospital

ClinicalTrials.gov Identifier:

NCT04373876

Other Study ID Numbers:

S-ICD-ITA

First Posted:

May 5, 2020

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Apr 13, 2021