Arrhythmias Detection in a Real World Population

NCT02275637 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Phase

Observational

Started

2014-09

Last updated

2025-07-08

Condition(s) studied

Appropriate and Inappropriate Shock Therapy With ICDArrhythmias Detection

Investigational drug(s) / intervention(s)

implantable cardioverter defibrillator

Study 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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (12)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02275637 on ClinicalTrials.gov ↗ ← All trials in Italy