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Completed

NCT Number: NCT00832975

AVAI: Atrial Ventricular Arrythmia Incidence

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Puerta de Hierro, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .

Acronym: AVAI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2009
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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