Atrial FibrillationNCT03496272
Atrial Fibrillation Cycle Length Measured on Transesophageal Echocardiography
An observational study of Atrial Fibrillation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 30 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-valvular atrial fibrillation
Who may be able to join
- atrial fibrillation
Who cannot join
- moderate or severe mitral stenosis
- prosthetic heart valve
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Yong Hyun Park, MD
About this study
Official title: Atrial Fibrillation (AF) Cycle Length Measured on Transesophageal Echocardiography : a Feasible Parameter for Predicting the Recurrence of AF in Patients With AF Converted to Sinus Rhythm After DC Cardioversion
Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV.
Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.
- 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.
AF free survival rate at 6 months after DCCV
Atrial fibrillation free state at 6 months after direct current cardioversion
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (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.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Hyun Park, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496272
- Sponsor's protocol ID
- PNUYH-IRB-05-2016-154
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation (AF) Cycle Length Measured on Transesophageal Echocardiography : a Feasible Parameter for Predicting the Recurrence of AF in Patients With AF Converted to Sinus Rhythm After DC Cardioversion
- ClinicalTrials.gov ID
- NCT03496272
- Acronym / sponsor ID
- PNUYH-IRB-05-2016-154
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 12 Apr 2018 (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.
Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV.
Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-valvular atrial fibrillation
Key inclusion criteria (1 listed)
- atrial fibrillation
Key exclusion criteria (2 listed)
- moderate or severe mitral stenosis
- prosthetic heart valve
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
AF free survival rate at 6 months after DCCV
Time frame: 6 month
Atrial fibrillation free state at 6 months after direct current cardioversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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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.
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 Pusan National University Yangsan Hospital 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 1 inclusion and 2 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 12 Apr 2018. 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 Yong Hyun Park, MD (82-55-360-2363, nadroj@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF free survival rate at 6 months after DCCV (time frame: 6 month). 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 12 Apr 2018.