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

NCT01203137 | Completed

• 1 other identifier: H-1009-014-331
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Regurgitation

Keywords

tricuspid regurgitation, severe

Outcome Measures

Primary Outcomes (1)

• clinical event

  Clinical events were 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.

  40 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We prospectively recruited consecutive patients with isolated (without any other valvular dysfunction) severe TR who underwent corrective surgery.

You may qualify if:

• severe tricuspid regurgitation

You may not qualify if:

• concomitant left-sided valve surgery
• significant coronary artery disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: January 1, 2009
• Primary Completion: February 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

KR (1)