AzTrials
AzTrials

Mitral Valve Repair SurgeryMVANCT01694251

Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography

An observational study of Mitral Valve Repair Surgery, run by Konkuk University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity of MS before the repair and excluding residual MS for immediate determination of the success of the repair procedure and postoperative… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Repair Surgery
How many people
86 participants
Where
1 siteSouth Korea
Study dates
Dec 2011to Mar 2012
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: mitral valve repair mitral stenosis

Who may be able to join

  • patients scheduled to undergo elective mitral valve repair surgery
  • more than moderate mitral stenosis
  • left atrial enlargement
  • signed written informed consent agreements

Who cannot join

  • urgent or emergency case
  • other concurrent valvular surgery
  • patient age < 18 years,
  • reduced left or right ventricular function (ejection fraction < 40%),
  • mitral regurgitation grade more than moderate
  • repeated surgery for cardiac valvular disease

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Konkuk University Medical Center

    Seoul, Seoul, 143-729

Other trials in South Korea

About this study

Official title: Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography

Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity of MS before the repair and excluding residual MS for immediate determination of the success of the repair procedure and postoperative prognosis. For this purpose, several methods have been applied by introperative transesophageal echocardiography (TEE): pressure half-time (PHT) of mitral inflow Doppler and 2-dimensional (2D) planimetry methods have been widely used in clinical practice. However, especially after MVP, the PHT method is usually unreliable because it usually underestimates the MVA due to various intraoperative hemodynamic factors.

The authors hypothesized that the MVA determined by 3D TEE would be more accurate than that by PHT during immediate post-MVP procedure in severe MS patients and comparable to postoperative MVA determined by MDCT. Therefore, the present study determined the MVA by using PHT, 3D planimetry and MDCT before and after the MVP procedure in severe MS patients and analyzed them to evaluate 3D TEE's utility for evaluation of MVA.

Read the detailed description

After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective MVP due to more than moderate MS and left atrial enlargement with or without atrial fibrillation (AFib) signed written informed consent agreements and prospectively participate in the present study.

In addition to the routine transthoracic echocardiographic evaluation, cardiac CT examination is performed in all recruited patients prior to surgery to determine MVA.

Induction of anesthesia and tracheal intubation are performed after the administration of intravenous etomidate 0.1-0.2 mg/kg and rocuronium 0.9 mg/kg followed by continuous infusion of remifentanil (0.5-1.0 mcg/kg/min). After tracheal intubation, sevoflurane (1.0 inspired vol%) and infusion of rocuronium (0.2 mg/kg/hr) are administered for anesthesia maintenance.

After anesthesia induction, pulmonary artery catheter (PAC) is placed in right internal jugular vein into pulmonary artery by pressure guidance and a 3D TEE probe (X-9™, Philips Medical Systems Andover, MA, USA) is inserted for the comprehensive intraoperative TEE examination using a 3D echocardiographic imaging platform (iE33; Philips Medical Systems, Andover, MA, USA). While momentarily turning off the ventilator, three consecutive velocity-time integrals (VTIs) of mitral inflow Doppler scans were obtained by applying the continuous wave Doppler parallel to the mitral inflow Color Doppler signal in the midesophageal long-axis view. In case of AFib, the biggest VTI among the 5 consecutive VTIs of the mitral inflow Doppler was used for determining PHT to detect maximal mitral inflow among irregular heartbeats. Immediately after recording the VTIs, a live 3D zoom "en face" MV view from the left atrium (LA) or left ventricle (LV) perspective is acquired.

As baseline data, MVA is determined by using PHT method (MVA-PHT): PHT of the mitral inflow deceleration slope is determined using stored mitral inflow Doppler VTI and the MVA are automatically calculated assuming MVA = 220/PHT. At the same time, a 2D image of the smallest MVA perpendicular to the mitral inflow at the maximal MV opening was achieved by post-processing including aligning and cropping of the acquired 3D images with an installed software (3DQ™ in Q-lab™, Philips, USA). MVA was determined by circumferential tracing of the leaflet edges of the MV opening in the cropped and reconstructed tomographic image from stored 3D volume image (MVA-3D) (Fig. 1). All MVA measurements were repeated 3 times within a minimal time interval by the same expert cardiac anesthesiologists with the mean value used for analysis.

All patients got a single type of MVP (Comprehensive Mitral Valve Apparatus Reconstruction™) consisting of following procedures under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon: restoration of a sufficient MV opening with repair of anterior or posterior MV leaflets, mitral commissure, and chordate; and lifting posterior annuloplasty using a flexible ready to use band. A Maze operation is additionally performed in patients who associated with Afib.

Immediately after the weaning from the CPB and achieving stable hemodynamics (mean arterial blood pressure > 65 mmHg, heart rate 60-90 beats per minute, cardiac index > 2.0 L/min/m2), MVA-PHT and MVA-3D are determined in the same manner as the baseline data acquisition.

The following intraoperative exclusion criteria are applied: 1) intraoperative conversion to MV replacement due to insufficient repair procedure, 2) the inability to delineate MV opening due to insufficient 3D imaging.

Within 7 postoperative days, the MVA-CT is determined again for comparison to other methods by an expert cardiac radiologist in the same manner which applied preoperatively.

Statistical analyses are conducted using SPSS 18.0 (SPSS Inc., Chicago, IL, USA). To assess intra-observer variability, the MVAs measured by PHT method and 3D planimetry with TEE are analyzed using intraclass correlation coefficient (ICC). The comparisons of MVA-PHT, MVA-3D, and MVA-CT before or after MVP are analysed used a One Way Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the Tukey method. The comparisons of the other continuous variables of echocardiographic findings are performed by paired t or Wilcoxon Signed Rank tests. The linear regression analysis is used to determine possible correlation between MVA by using each method. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.

Keywords
mitral valve area, pressure half time, 3 dimensional transesophageal echocardiography, computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mitral valve area determined by 3D planimetry

    Measured: within 1 hour after the weaning from CPB

  2. mitral valve area determined by pressure-half time

    Measured: within 1 hour after the weaning from CPB

  3. mital valve area determined by multi-detactor CT scan

    Measured: within 7 days weaning from CPB

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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
Prospective
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01694251
Sponsor's protocol ID
KUH1160027
Acronym
MVA
Status last verified
Sep 2012
First submitted
23 Sep 2012
Last updated
27 Sep 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Valve Repair Surgery, run by Konkuk University 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 4 inclusion and 6 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 27 Sep 2012. 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?

mitral valve area determined by 3D planimetry (time frame: within 1 hour after the weaning from CPB). The study lists 3 primary outcomes in all. 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 27 Sep 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in