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DIAAF: Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04654806
Collaborator
(none)
200
Enrollment
1
Location
36.2
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single-center, prospective cohort study to investigate non-invasive method to assess left ventricular diastolic function using echocardiography. Patients with AF who are referred radiofrequency catheter ablation (RFA) will be included prospectively. Transthoracic echocardiography will be performed during, immediately before RFA and with no cardiovascular medication taken between the exams so that the loading conditions during catheterization and echocardiography are as similar as possible. We will validate previously proposed echocardiographic parameters and creat an algorithm to identify the relationship between echocardiographic parameters of diastolic function and invasively measured LA pressure in patients with atrial fibrillation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation
    Actual Study Start Date :
    Nov 25, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Association between mean left atrial pressure and echocardiographic parameters [up to 12 weeks after collecting all data]

      Correlation between echocardiographic parameters or algorithm to estimate invasively measured left atrial pressure. Echocardiographic parameters: E/A ratio, E velocity, e' velocity, E/e', IVRT. LV strain, RV strain,, LA strain, Vp, E/Vp, LA volume index, TV V max, and Peak acceleration rate of mitral E velocity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult ≥ 19 year-old

    • Patients who scheduled to perform radiofrequency catheter ablation for atrial fibrillation

    • Patients who had paroxysmal, persistent, or chronic AF

    • Patients provided with the written, informed consent to participate in this study

    Exclusion Criteria:

    • Patients with prosthetic valve

    • Life expectancy < 12 months

    • Subject who the investigator deems inappropriate to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Jong-Won Ha, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04654806
    Other Study ID Numbers:
    • 4-2020-1105
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 10, 2022