Atrial Fibrillation Prediction Trial.

Last updated: January 27, 2016
Sponsor: University of Athens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT02307032
3037SH
07062011
  • Ages 30-80
  • All Genders

Study Summary

Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the lastthree years. Patients during screening must maintaining Sinus Rhythm.

Exclusion

Exclusion Criteria:

  • previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervoussystem, alcoholism, diseases affecting seriously the survival and absence of adequatecooperation for the study

Study Design

Total Participants: 500
Study Start date:
September 01, 2014
Estimated Completion Date:
December 31, 2020

Study Description

Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. In the presence of the Arrhythmia the risk of stroke increases five fold while the congestive heart failure and the mortality rates are increasing significantly also.After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches. The study will include > 500 patients 30-80 years old. Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm. Exclusion criteria are substrate of severe valvular diseases, congenital heart disease, previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study. Screening will include 12 lead surface digital ECG, 30 min High Resolution (1000 Hz) ECG recording from 3 pseudo orthogonal x,y,z leads system, and complete ECHO study (2D, PWD, TDI, Strain).Among other indices will be analyzed: P duration, P index, P dispersion, P wave signal for Late potentials, for Wavelets, PQ/RR Dynamics, Heart Rate Dynamics and various markers for the autonomic nervous system status.Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.Secondary end point is permanent AF during a period of 36 months after recruitment in study.

Connect with a study center

  • Cardiology Department, Hippokration Hospital

    Athens, Attiki
    Greece

    Site Not Available

  • First Department of Cardiology, Medical School, National & Kapodistrian University of Athens

    Athens, Attiki
    Greece

    Site Not Available

  • Cardiology Department Thriasio Hospital

    Eleysina, Attiki
    Greece

    Site Not Available

  • Cardiology Department, Sismanogleion Hospital

    Marousi,
    Greece

    Active - Recruiting

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