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. Identifier: NCT00832975
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : March 3, 2015
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
St. Jude Medical

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Ventricular Tachycardia
Atrial Fibrillation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
St Jude Medical ICD/CRT-D St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients

Participant Flow:   Overall Study
    St Jude Medical ICD/CRT-D
STARTED   157 
Lost to Follow-up                7 
Protocol Violation                6 
Death                5 
Physician Decision                4 
Withdrawal by Subject                3 
Other reasons                14 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients

Reporting Groups
St Jude Medical ICD/CRT-D St Jude Medical ICD/CRT-D Device implanted patients

Baseline Measures
   St Jude Medical ICD/CRT-D 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 61.67  (13.39) 
[Units: Participants]
Female   35 
Male   122 

  Outcome Measures

1.  Primary:   Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)   [ Time Frame: 24 months ]

2.  Secondary:   Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure   [ Time Frame: 24 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr Ignacio Fernández Lozano
Organization: Hospital Clínico Universitario Puerta de Hierro
phone: 913445000

Responsible Party: St. Jude Medical Identifier: NCT00832975     History of Changes
Other Study ID Numbers: CR08003ES
First Submitted: January 29, 2009
First Posted: January 30, 2009
Results First Submitted: February 17, 2015
Results First Posted: March 3, 2015
Last Update Posted: December 2, 2016