Atrial FibrillationDIAAFNCT04654806
Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who scheduled to perform radiofrequency catheter ablation for atrial fibrillation
Who may be able to join
- 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
Who cannot join
- Patients with prosthetic valve
- Life expectancy < 12 months
- Subject who the investigator deems inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Jong-Won Ha, 82-2-2228-8464, jiwonseo1430@gmail.com
About this study
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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 12 weeks after collecting all data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start25 Nov 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Won Ha, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654806
- Sponsor's protocol ID
- 4-2020-1105
- Acronym
- DIAAF
- Status last verified
- May 2022
- First submitted
- 26 Nov 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04654806
- Acronym / sponsor ID
- DIAAF / 4-2020-1105
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who scheduled to perform radiofrequency catheter ablation for atrial fibrillation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with prosthetic valve
- Life expectancy < 12 months
- Subject who the investigator deems inappropriate to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between mean left atrial pressure and echocardiographic parameters
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Won Ha principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong-Won Ha (82-2-2228-8464, jiwonseo1430@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between mean left atrial pressure and echocardiographic parameters (time frame: up to 12 weeks after collecting all data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.