Atrial Fibrillation Clinical Trial
— AVAIOfficial title:
Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
NCT number | NCT00832975 |
Other study ID # | CR08003ES |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2008 |
Est. completion date | December 2013 |
Verified date | February 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Puerta de Hierro | Madrid | |
Spain | Hospital Clínico Universitario Virgen de la Victoria | Málaga |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Spain,
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 |
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