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 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

January 29, 2009
February 17, 2015
December 2008
February 2013   (final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT00832975 on ClinicalTrials.gov Archive Site
Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 ]
Not Provided
Not Provided
 
AVAI: Atrial Ventricular Arrythmia Incidence
Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients implanted with a St. Jude Medical ICD

  • Ventricular Tachycardia
  • Atrial Fibrillation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
December 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00832975
CR08003ES
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Ignacio Fernández Lozano, PhD. Hospital Universitario Puerta de Hierro
Principal Investigator: Javier Alzueta, PhD Hospital Clinico Universitario Virgen de la Victoria
St. Jude Medical
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP