Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

AVAI: Atrial Ventricular Arrythmia Incidence (AVAI)

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: January 29, 2009
Last updated: October 21, 2016
Last verified: October 2016
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Ventricular Tachycardia
Atrial Fibrillation

Study Type: Observational
Study Design: 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) .

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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:
  • Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure [ Time Frame: 24 months ]

Enrollment: 157
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00832975

Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
St. Jude Medical
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

Responsible Party: St. Jude Medical Identifier: NCT00832975     History of Changes
Other Study ID Numbers: CR08003ES
Study First Received: January 29, 2009
Results First Received: February 17, 2015
Last Updated: October 21, 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017