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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01694251
First received: September 23, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • mitral valve area determined by 3D planimetry [ Time Frame: within 1 hour after the weaning from CPB ] [ Designated as safety issue: No ]
  • mitral valve area determined by pressure-half time [ Time Frame: within 1 hour after the weaning from CPB ] [ Designated as safety issue: No ]
  • mital valve area determined by multi-detactor CT scan [ Time Frame: within 7 days weaning from CPB ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 23, 2012
Last Updated: September 23, 2012
Health Authority: Korea: Institutional Board Review

Keywords provided by Konkuk University Medical Center:
mitral valve area
pressure half time
3 dimensional transesophageal echocardiography
computed tomography

ClinicalTrials.gov processed this record on October 19, 2014