Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— DIAAF  

Official title:

Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654806
• Other study ID #: 4-2020-1105
• Status: Recruiting
• Start date: November 25, 2020
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Yonsei University
• Contact: Jong-Won Ha
• Phone: 82-2-2228-8464
• Email: jiwonseo1430[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between mean left atrial pressure and echocardiographic parameters	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	up to 12 weeks after collecting all data