AVAI: Atrial Ventricular Arrythmia Incidence

Completed

• Conditions: Ventricular Tachycardia; Atrial Fibrillation

• Registration Number: NCT00832975
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Results First Submitted: 2015-02-17
• Results First Submitted QC: 2015-02-17
• Results First Posted: 2015-03-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)	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 Outcome Measures

Name	Time	Method
Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure	24 months

Trial Locations

Locations (2)

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain