Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

AVAI: Atrial Ventricular Arrythmia Incidence

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: January 29, 2009
Last updated: July 26, 2013
Last verified: July 2013

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 a DAI.

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) AF Episodes devices detected (> 30 sec) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Mortality Hospitalization rate due to cardiovascular reasons or heart failure Slow Ventricular Tachycardia and Atrial fibrillation Episodes Cardiac Symptoms [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 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
Genders Eligible for Study:   Both
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 SJM ICD, mono or bicameral according the ACC/AHA/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 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
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Ignacio Fernández Lozano, PhD. Hospital Universitario Puerta de Hierro
  More Information

No publications provided

Responsible Party: St. Jude Medical Identifier: NCT00832975     History of Changes
Other Study ID Numbers: CR08003ES
Study First Received: January 29, 2009
Last Updated: July 26, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on February 25, 2015