Atrial FibrillationNCT00542659
Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure
An observational study of Atrial Fibrillation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2005to Feb 2008
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation
Who may be able to join
- The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation
Who cannot join
- Coronary heart disease
- Congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma ANP and NT-pro-BNP, Atrial Anatomical Change May Determine the Outcome of Maze Operation
The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure.
The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Maze procedure
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionFeb 2008
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 Samsung Medical CenterThe 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Young Keun On, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542659
- Sponsor's protocol ID
- 2005-02-019
- Status last verified
- Jul 2011
- First submitted
- 10 Oct 2007
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma ANP and NT-pro-BNP, Atrial Anatomical Change May Determine the Outcome of Maze Operation
- ClinicalTrials.gov ID
- NCT00542659
- Acronym / sponsor ID
- 2005-02-019
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Maze procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Oct 2007 (estimated)
- 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.
The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure.
The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation
Key inclusion criteria (1 listed)
- The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation
Key exclusion criteria (2 listed)
- Coronary heart disease
- Congestive heart failure
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 recurrence
Time frame: year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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
Recruiting
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.
Young Keun On, MD principal investigator
Samsung Medical Center
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 Samsung Medical Center 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: finished, as of the sponsor's last update on 25 Jul 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: year). 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 25 Jul 2011.