AVAI: Atrial Ventricular Arrythmia Incidence

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
First received: January 29, 2009
Last updated: August 6, 2015
Last verified: August 2015
Results First Received: February 17, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Ventricular Tachycardia
Atrial Fibrillation

  Participant Flow
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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
Single Arm St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients

Participant Flow:   Overall Study
    Single Arm  
STARTED     157  
COMPLETED     118  
Lost to Follow-up                 7  
Protocol Violation                 6  
Death                 5  
Physician Decision                 4  
Withdrawal by Subject                 3  
Other reasons                 14  

  Baseline Characteristics
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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
Single Arm St Jude Medical ICD/CRT-D Device implanted patients

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  61.67  (13.39)  
[units: participants]
Female     35  
Male     122  

  Outcome Measures
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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
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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
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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
e-mail: iflozano@secardiologia.es

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832975     History of Changes
Other Study ID Numbers: CR08003ES
Study First Received: January 29, 2009
Results First Received: February 17, 2015
Last Updated: August 6, 2015
Health Authority: Spain: Spanish Agency of Medicines