Clinical Trial: Balloon Valvuloplasty Registry

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

Brief Summary: To establish a registry in order to collect and analyze baseline and outcome data on patients with severe valvular stenosis treated with balloon valvuloplasty.

Detailed Summary:

BACKGROUND:

Valvular stenosis or incompetence results in an estimated 41,000 valve replacements in the United States each year. These replacements are equally distributed between the aortic and mitral valves. An estimated 60 percent of aortic valve replacements are the result of valve stenosis; 20-30 percent of mitral valve replacements are due to stenosis. The risk of operative mortality in single valve replacement ranges from 3 percent to as high as 15 percent depending upon patient characteristics. Morbidity associated with open heart procedures includes wound infection, reoperation for bleeding, and post-operative pain. Most patients with artificial valves require anticoagulant therapy for the rest of their lives and thus face the competing risks of hemorrhage and valve thrombosis/embolism. In addition, there are a number of patients with aortic stenosis who are not candidates for aortic valve replacement because of unacceptable operative risks who might be dramatically improved by balloon valvuloplasty.

The pathophysiologic processes underlying valvular stenosis at the aortic and mitral positions are quite different. Mitral stenosis is an outcome of rheumatic fever. Rheumatic fever is quite unusual in this country but it and its sequelae, rheumatic valvular disease, persist as major public health problems in the Third World. Aortic stenosis is most commonly the result of calcific degeneration of a normal tricuspid aortic valve in the elderly or the result of rheumatic fever but can also develop in a congenital bicuspid aortic valve which becomes progressively more stenotic with age and the wear of abnormal flow patterns.

The results of surgical valvuloplasty differ for mitral and aortic valves. Surgical valvuloplasty (commissurotomy) for mitral stenosis is currently a
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Heart, Lung, and Blood Institute (NHLBI)

Dates:
Date Received: May 25, 2000
Date Started: June 1987
Date Completion: November 1994
Last Updated: June 23, 2005
Last Verified: May 2000