Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Tachycardia
- Sponsor
- Abbott Medical Devices
- Enrollment
- 157
- Locations
- 2
- Primary Endpoint
- Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
Detailed Description
The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
- •Patient has signed the study specific Informed consent document.
- •Patient is older than 18 years of age
Exclusion Criteria
- •Patient has a permanent Atrial Fibrillation
- •Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
- •Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
- •Patient requires cardiac resynchronization
- •Patient has Brugada Syndrome
- •Patient has long QT Syndrome
- •Patient has a device replacement;
- •Patient is pregnant or nursing
- •Patient is unable to attend the follow-up visits
Outcomes
Primary Outcomes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
Time Frame: 24 months
Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is \>30sec
Secondary Outcomes
- Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure(24 months)