AVAI: Atrial Ventricular Arrythmia Incidence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00832975
First received: January 29, 2009
Last updated: February 17, 2015
Last verified: February 2015
  Purpose

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


Condition
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 Fibrilation (AF) Episodes Devices Detected (> 30 Sec) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Slow Ventricular Tachycardia will be considered as a tachycardia between 120-150 bpm and > 30sec AF Episodes will be considered as those >30sec


Secondary Outcome Measures:
  • Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

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

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
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 ClinicalTrials.gov identifier: NCT00832975

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

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: February 17, 2015
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 29, 2015