Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography

NCT01694251 | Completed DMC

• 1 other identifier: KUH1160027
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mitral Valve Repair Surgery

Keywords

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

Outcome Measures

Primary Outcomes (3)

• mitral valve area determined by 3D planimetry

  within 1 hour after the weaning from CPB

• mitral valve area determined by pressure-half time

  within 1 hour after the weaning from CPB

• mital valve area determined by multi-detactor CT scan

  within 7 days weaning from CPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

mitral valve repair mitral stenosis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

Study Officials

• Tae-Yop Kim, MD PhD

  Konkuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesiology

Study Record Dates

• First Submitted: September 23, 2012
• First Posted: September 27, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

KR (1)