NCT02275637
Recruiting
N/A
Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
Fondazione IRCCS Policlinico San Matteo di Pavia12 sites in 1 country10,000 target enrollmentSeptember 1, 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Appropriate and Inappropriate Shock Therapy With ICD
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Enrollment
- 10000
- Locations
- 12
- Primary Endpoint
- Patients with ICD therapy (shock)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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).
Investigators
Maurizio Eugenio Landolina
EP and Pacing Laboratory Director
Fondazione IRCCS Policlinico San Matteo di Pavia
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patients with ICD therapy (shock)
Time Frame: 24 months
Clinical or instrumental parameters that could predict the appropriate ICD therapies
Secondary Outcomes
- Patients with inappropriate shock therapy(24 months)
- Time to first ICD therapy(24 months)
- Predictors of onset and Atrial Fibrillation (AF) burden(24 months)
- Incidence of ICD therapies(24 months)
Study Sites (12)
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