Arrhythmias Detection in a Real World Population

Recruiting

• Conditions: Appropriate and Inappropriate Shock Therapy With ICD; Arrhythmias Detection

• Registration Number: NCT02275637
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Ospedale Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

P.O. Rodolico-San Marco; 🇮🇹 Catania, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

ASST Rhodense- Ospedale di Rho; 🇮🇹 Milan, Italy

IRCCS S.Ambrogio-Galeazzi; 🇮🇹 Milan, Italy

Ospedale dei Colli Monaldi; 🇮🇹 Naples, Italy

University of Padua; 🇮🇹 Padua, Italy

IRCC Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliero Universitaria Pisa Cisanello; 🇮🇹 Pisa, Italy

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