NCT02307032

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

December 1, 2014

Last Update Submit

January 27, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation Relapses PredictionP wave Signal Averaged ECGP wave WaveletsStrainTissue Doppler Imaging

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation Relapse

    Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.

    12 months

Secondary Outcomes (1)

  • Permanent Atrial Fibrillation

    36 months

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include \> 500 patients 30-80 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cardiology Department, Hippokration Hospital

Athens, Attica, Greece

ACTIVE NOT RECRUITING

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

Athens, Attica, Greece

ACTIVE NOT RECRUITING

Cardiology Department Thriasio Hospital

Eleysina, Attica, Greece

ACTIVE NOT RECRUITING

Cardiology Department, Sismanogleion Hospital

Marousi, Greece

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationSprains and Strains

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Petros Arsenos, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petros Arsenos, MD, PhD

CONTACT

00306974338896arspetr@otenet.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Petros Arsenos, MD, PhD

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2019

Study Completion

December 1, 2020

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

GR(4)