AVAI: Atrial Ventricular Arrythmia Incidence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

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Detailed Description

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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.

Conditions

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Ventricular Tachycardia Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No