Arrhythmias Detection in a Real World Population

Appropriate and Inappropriate Shock Therapy With ICD Clinical Trial

— RHYTHM DETECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275637
• Other study ID #: 20140002277 del 27/05/2014
• Status: Recruiting
• Start date: September 2014
• Est. completion date: December 2023

Study information

• Verified date: May 2021
• Source: IRCCS Policlinico S. Matteo
• Contact: Maurizio Eugenio Landolina, MD
• Phone: 0382.501276
• Email: clinical-estimate[@]isis.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appropriate and Inappropriate Shock Therapy With ICD
• Arrhythmias Detection
• Arrhythmias, Cardiac

Intervention

Device:
• implantable cardioverter defibrillator

Locations

Country	Name	City	State
Italy	IRCC Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Maurizio Eugenio Landolina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with ICD therapy (shock)	Clinical or instrumental parameters that could predict the appropriate ICD therapies	24 months
Secondary	Patients with inappropriate shock therapy	Clinical or instrumental parameters that could predict the inappropriate ICD therapies	24 months
Secondary	Incidence of ICD therapies	Number of patients with ICD therapies	24 months
Secondary	Time to first ICD therapy		24 months
Secondary	Predictors of onset and Atrial Fibrillation (AF) burden		24 months