Status:

COMPLETED

AVAI: Atrial Ventricular Arrythmia Incidence

Lead Sponsor:

Abbott Medical Devices

Conditions:

Ventricular Tachycardia

Atrial Fibrillation

Eligibility:

All Genders

18+ years

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 Fibr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

157 Patients enrolled

Trial Details

Trial ID

NCT00832975

Start Date

December 1 2008

End Date

December 1 2013

Last Update

February 21 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Hospital Universitario Puerta de Hierro

Madrid, Spain, 28222

2

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Spain