AVAI: Atrial Ventricular Arrythmia Incidence

NCT00832975 | Completed Results

• 1 other identifier: CR08003ES
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ventricular Tachycardia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)

  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

  24 months

Secondary Outcomes (1)

• Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a St. Jude Medical ICD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Spain

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Ignacio Fernández Lozano
• Organization: Hospital Clínico Universitario Puerta de Hierro

iflozano@secardiologia.es

913445000

Study Officials

• Ignacio Fernández Lozano, PhD.

  Hospital Universitario Puerta de Hierro

  PRINCIPAL INVESTIGATOR

• Javier Alzueta, PhD

  Hospital Clinico Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 21, 2019
• Results First Posted: March 3, 2015

Record last verified: 2019-02

Locations

ES (2)