RecruitingNCT02275637

Arrhythmias Detection in a Real World Population

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


Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

10,000 participants

Start Date

Sep 1, 2014

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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 Criteria2

  • 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

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Interventions

DEVICEimplantable cardioverter defibrillator

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

Florence, 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

Azienda Ospedaliera S.Andrea

Rome, Italy

Ospedale Bambino Gesù

Rome, Italy

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NCT02275637