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N/A N=111

Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation

Mitral Valve Insufficiency · Atrial Fibrillation · Heart Failure

Enrolled (actual)
111
Serious AEs
8.1%
Results posted
Jun 2011
Primary outcome: Primary: Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization — 25.5 mmHg

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Cardiac catheterization (Procedure)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Kaohsiung Veterans General Hospital.
Primary completion
Jan 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization
25.5
SECONDARY
Number of Participants With Post-operation Atrial Fibrillation
36
SECONDARY
Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period
9

Summary

A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function. Thus, the LA volume provides a long-term view of whether the patient has diastolic dysfunction, regardless of the loading conditions present at the examination, such as hemoglobin A1c in diabetes mellitus. To date, the relation between the LA volume and left ventricular (LV) filling pressure has not been confirmed directly by simultaneous echocardiographic catheterization. The present study, therefore, assessed the correlation between the LA volume and LV filling pressure in patients with severe mitral regurgitation (MR). Because the LA pressure increases to maintain adequate LV diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch the atrial myocardium. Therefore, the lower the ability of the left atrium to stretch, the greater the pressure in the left atrium. The study is designed to assess 1) the relationship between LV filling pressure and LA distensibility, and 2) the power of left atrial distensibility to predict the prognosis, including operation mortality, the rate of post-operation atrial fibrillation, and late heart failure event in patients with severe mitral regurgitation.

Eligibility Criteria

Inclusion Criteria

  • Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study.

Exclusion Criteria

  • Presence of mitral stenosis
  • More than mild severity of aortic valvular problem
  • Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
  • Rhythm other than sinus rhythm
  • Inadequate image quality
  • Lack of informed consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01172184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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