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
Bottom Line
View on ClinicalTrials.gov: NCT01172184 ↗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
| Outcome | Result | p-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
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.