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Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation

NCT ID: NCT01203137

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Brief Summary

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Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.

Detailed Description

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We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.

Conditions

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Tricuspid Regurgitation

Keywords

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tricuspid regurgitation, severe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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tricuspid regurgitation, severe

To be included in the present study, the following 3 criteria for severe TR should be met based on the preoperative echocardiography: (1) TR jet \> 30% of right atrial area, (2) inadequate cusp coaptation, and (3) systolic flow reversal in the hepatic vein.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* severe tricuspid regurgitation

Exclusion Criteria

* concomitant left-sided valve surgery
* significant coronary artery disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Kwan Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1009-014-331

Identifier Type: -

Identifier Source: org_study_id