RHYTHM DETECT: Arrhythmias Detection in a Real World Population

• Sponsor: Maurizio Eugenio Landolina (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02275637
• Collaborator: (none)
• Enrollment: 4,800
• Location: 1
• Duration (Months): 111
• Patients Per Site Per Month: 43.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Appropriate and Inappropriate Shock Therapy With ICD; Arrhythmias Detection	Device: implantable cardioverter defibrillator

Study Design

• Study Type: Observational
• Anticipated Enrollment: 4800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Patients with ICD therapy (shock) [24 months]

   Clinical or instrumental parameters that could predict the appropriate ICD therapies

Secondary Outcome Measures

1. Patients with inappropriate shock therapy [24 months]

   Clinical or instrumental parameters that could predict the inappropriate ICD therapies

2. Incidence of ICD therapies [24 months]

   Number of patients with ICD therapies

3. Time to first ICD therapy [24 months]

4. Predictors of onset and Atrial Fibrillation (AF) burden [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCC Policlinico San Matteo	Pavia		Italy

Sponsors and Collaborators

• Maurizio Eugenio Landolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Eugenio Landolina, EP and Pacing Laboratory Director, IRCCS Policlinico S. Matteo
• ClinicalTrials.gov Identifier: NCT02275637
• Other Study ID Numbers: 20140002277 del 27/05/2014
• First Posted: Oct 27, 2014
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Keywords provided by Maurizio Eugenio Landolina, EP and Pacing Laboratory Director, IRCCS Policlinico S. Matteo: Implantable Cardioverter-Defibrillators; Ventricular Fibrillation; ventricular Tachycardia
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of May 6, 2021