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Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography (MVA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694251
First Posted: September 27, 2012
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
  Purpose

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.


Condition
Mitral Valve Repair Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of Mitral Valve Area After Mitral Valve Repair Surgery for Mitral Stenosis Using 3-dimensional Transesophageal Echocardiography

Further study details as provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:

Primary Outcome Measures:
  • mitral valve area determined by 3D planimetry [ Time Frame: within 1 hour after the weaning from CPB ]
  • mitral valve area determined by pressure-half time [ Time Frame: within 1 hour after the weaning from CPB ]
  • mital valve area determined by multi-detactor CT scan [ Time Frame: within 7 days weaning from CPB ]

Enrollment: 86
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
mitral valve repair mitral stenosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694251


Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Tae-Yop Kim, MD PhD Konkuk University
  More Information

Responsible Party: Tae-Yop Kim, MD PhD, professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01694251     History of Changes
Other Study ID Numbers: KUH1160027
First Submitted: September 23, 2012
First Posted: September 27, 2012
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
mitral valve area
pressure half time
3 dimensional transesophageal echocardiography
computed tomography