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OpenTrials
Recruiting

NCT Number: NCT02275637

Arrhythmias Detection in a Real World Population

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).

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Key information

Conditions

Appropriate and Inappropriate Shock Therapy With ICD Arrhythmias Detection Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Papa Giovanni XXIII, Bergamo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

Primary outcomes

  1. Patients with ICD therapy (shock)

    Time frame: 24 months

    Clinical or instrumental parameters that could predict the appropriate ICD therapies

Secondary outcomes

  1. Patients with inappropriate shock therapy

    Time frame: 24 months

    Clinical or instrumental parameters that could predict the inappropriate ICD therapies

  2. Incidence of ICD therapies

    Time frame: 24 months

    Number of patients with ICD therapies

  3. Time to first ICD therapy

    Time frame: 24 months

  4. Predictors of onset and Atrial Fibrillation (AF) burden

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Vicentini, MD

CONTACT

[email protected]

0382.503715 ext. 0039

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: RHYTHM DETECT

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Oct 27, 2014
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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