Heart Failure Clinical Trial
Official title:
Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.
Some patients with left ventricular systolic dysfunction (LVSD) have an inefficient pumping
function. These patients have been shown to benefit from a device therapy known as
biventricular pacing. Biventricular pacing causes a more coordinated contraction of the
heart chambers resulting in improvement in the pumping ability of the heart and blood
pressure. Cardiac Resynchronization Therapy (CRT) has established itself as a proven therapy
for congestive heart failure in adults, patients showing improvement in exercise tolerance,
quality of life, and survival.
In cardiac surgery, a significant number of these patients with left ventricular systolic
dysfunction require postoperative pacing. Right ventricular pacing has been shown to be
hemodynamically deleterious Whether biventricular pacing in patients with LVSD improves
patient outcomes after heart surgery has not been investigated.
The aim of this crossover trial is to compare conventional ventricular pacing and
DDD-biventricular in post operative patients with a pre operative ejection fraction less
than 45%, in a prospective randomized setting.
We would like to determine whether biventricular pacing optimized by trans thoracic
echocardiography of left ventricular, immediately after heart surgery in patients with LVSD
will improve the heart function.
Immediately after surgery, the patients will receive atrio ventricular conventional right
ventricular pacing, or biventricular pacing depending upon the treatment arm that they were
randomized to.
The primary end point is a 15 % improvement in index cardiac measured by thermal dilution
and/or echocardiography in intensive care unit.
Furthermore, Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T
(cTnT), will be measured in patients undergoing elective cardiac surgery 12 h, 24 h, 48 h
and 72 hours after.
This study is important because of a high probability of clinical benefit.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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