Arrhythmias Detection in a Real World Population (RHYTHM DETECT)

May 4, 2021 updated by: Maurizio Eugenio Landolina

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy
        • Recruiting
        • IRCC Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study requires patients implanted with a defibrillator that meet all inclusion/exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with ICD therapy (shock)
Time Frame: 24 months
Clinical or instrumental parameters that could predict the appropriate ICD therapies
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maurizio Eugenio Landolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (ESTIMATE)

October 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140002277 del 27/05/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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