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RESEARCH STUDY
EVALUATING THE ROLE OF PACEMAKERS
Sick Sinus Syndrome (SSS) is a
condition affecting individuals with structural heart disease, more commonly occurring in
individuals over 65 years old. SSS affects the ability of the heart to generate a heart
beat. Consequently, the heart may slow down, or "pause", for periods of several
seconds at a time. When this happens, a fainting spell may occur and an individual can
fall or injure him/herself. Pacemakers are widely used to correct this electrical rhythm
disturbance of the heart.
A permanent
pacemaker is a small electronic device (about the size of a box of paper clips), which is
implanted under the skin (usually below the collar bone), and programmed to generate and
regulate the heart beat. One or two wires or "leads" are placed within the heart
and connected to the generator. We usually implant permanent pacemakers in the cardiac
catheterization laboratory.
Currently in the
United States, approximately one third of patients who have SSS, receive a dual-chamber
pacemaker (two leads, one in the right upper and one in the right lower chambers of the
heart). The other two thirds have single-chamber pacemakers (one lead inside the right
lower chamber alone). Single-chamber pacemakers are simpler, cost a little less, and tend
to last a few years longer. Dual -chamber pacemakers are a little more difficult to put
in, cost a little more, and have a slightly shorter battery life. However, they allow the
heart a more normal function. There is still a controversy among cardiologists as to which
kind of pacemaker is better for patients with SSS.
The purpose of this study is to
determine whether or not the dual -chamber pacemaker, even though it is more expensive and
has a shorter battery life, is better for patients with Sick Sinus Syndrome. Patients who
present with SSS will be randomized to either mode and will be followed for two to five
years. Quality of life will also be closely monitored. The long-term results of this trial
will help define the optimal treatment for this important subset of patients. Sponsor:
Mount Sinai / Duke Clinical Research Institute, 1997 to present.
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