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AVAI: Atrial Ventricular Arrythmia Incidence (AVAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00832975
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : March 3, 2015
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

Condition or disease
Ventricular Tachycardia Atrial Fibrillation

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 Design
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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
Study Start Date : December 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : December 2013

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a St. Jude Medical ICD
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832975


Locations
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Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Ignacio Fernández Lozano, PhD. Hospital Universitario Puerta de Hierro
Principal Investigator: Javier Alzueta, PhD Hospital Clinico Universitario Virgen de la Victoria
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00832975    
Other Study ID Numbers: CR08003ES
First Posted: January 30, 2009    Key Record Dates
Results First Posted: March 3, 2015
Last Update Posted: February 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease