AVAI: Atrial Ventricular Arrythmia Incidence - Full Text View

Sponsor:	St. Jude Medical
Information provided by (Responsible Party):	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00832975

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 a DAI.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

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:	November 2013
Estimated Primary Completion Date:	November 2012 (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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832975

Locations

Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Ignacio Fernández Lozano, PhD.

Hospital Universitario Puerta de Hierro

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
Last Updated:	November 28, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Accelerated Idioventricular Rhythm

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012