AVAI: Atrial Ventricular Arrythmia Incidence

Atrial Fibrillation Clinical Trial

— AVAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832975
• Other study ID #: CR08003ES
• Status: Completed
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)	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	24 months
Secondary	Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure		24 months