Biventricular Pacing After Cardiopulmonary Bypass
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2018 |
| Start Date: | October 2006 |
| End Date: | March 2012 |
The purpose of this study is to investigate the efficacy of optimized temporary biventricular
pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and
an intraventricular conduction delay. This study will compare extended temporary
biventricular pacing versus standard of care by assessing patients randomized to the two
groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic
circulatory support in the intensive care unit. In addition, effects of biventricular pacing
will be tested in all patients, at three time points, using different measures of blood flow.
Results from this research will demonstrate whether temporary BiVP improves cardiac output
after open-heart surgery and whether ventricular pacing optimization increases cardiac output
in this setting. Success would lead to the development of recommendations for use of BiVP
postoperatively and would stimulate the development of pacemakers with appropriate features.
The primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index
(CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as
measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining
POPT at three time points within 24 hours of surgery. The investigator will examine which
forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures
of perfusion and cardiac function. The investigator will also analyze survival, length of
stay, incidence of arrhythmias, and cost of postoperative care.
pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and
an intraventricular conduction delay. This study will compare extended temporary
biventricular pacing versus standard of care by assessing patients randomized to the two
groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic
circulatory support in the intensive care unit. In addition, effects of biventricular pacing
will be tested in all patients, at three time points, using different measures of blood flow.
Results from this research will demonstrate whether temporary BiVP improves cardiac output
after open-heart surgery and whether ventricular pacing optimization increases cardiac output
in this setting. Success would lead to the development of recommendations for use of BiVP
postoperatively and would stimulate the development of pacemakers with appropriate features.
The primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index
(CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as
measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining
POPT at three time points within 24 hours of surgery. The investigator will examine which
forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures
of perfusion and cardiac function. The investigator will also analyze survival, length of
stay, incidence of arrhythmias, and cost of postoperative care.
Biventricular pacing (BiVP) reverses intraventricular conduction delay (IVCD) and left
ventricular (LV) dysfunction in dilated cardiomyopathy (DCM). BiVP improves LV function and
cardiac index (Cl) at no energy cost. In the MIRACLE trial, in patients with DCM, IVCD and LV
ejection fraction <35%, demonstrated improved subjective and objective measures of exercise
tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not
fully developed, and 30% of recipients are "nonresponders," at a cost of more than $2
billion/year. Preliminary data suggest that BiVP can benefit patients with low output states
after cardiac surgery. This study will assess surgical application of BiVP while assessing
mechanisms of action and optimization. 190 cardiac surgery patients will be randomized with
LV dysfunction preoperatively to paced and standard of care groups. BiVP will be optimized
and continued postoperatively until patients are stable. BiVP will be assessed transiently in
all patients at three time points. The primary end point is a 15% improvement in thermal
dilution Cl measured in the intensive care unit (ICU). Effects of heart rate,
atrioventricular delay, ventricular pacing site, and interventricular delay on Cl will be
assessed using a randomized sequence of data collection. Secondary endpoints include
incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality,
and ICU costs. These studies are important because of a high probability of clinical benefit.
The methods employed will provide precision, breadth of measurement, and range of pacing
sites superior to any other setting. The protocol will provide new and important scientific
information that will benefit not only surgical patients but also the general population of
BiVP recipients.
ventricular (LV) dysfunction in dilated cardiomyopathy (DCM). BiVP improves LV function and
cardiac index (Cl) at no energy cost. In the MIRACLE trial, in patients with DCM, IVCD and LV
ejection fraction <35%, demonstrated improved subjective and objective measures of exercise
tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not
fully developed, and 30% of recipients are "nonresponders," at a cost of more than $2
billion/year. Preliminary data suggest that BiVP can benefit patients with low output states
after cardiac surgery. This study will assess surgical application of BiVP while assessing
mechanisms of action and optimization. 190 cardiac surgery patients will be randomized with
LV dysfunction preoperatively to paced and standard of care groups. BiVP will be optimized
and continued postoperatively until patients are stable. BiVP will be assessed transiently in
all patients at three time points. The primary end point is a 15% improvement in thermal
dilution Cl measured in the intensive care unit (ICU). Effects of heart rate,
atrioventricular delay, ventricular pacing site, and interventricular delay on Cl will be
assessed using a randomized sequence of data collection. Secondary endpoints include
incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality,
and ICU costs. These studies are important because of a high probability of clinical benefit.
The methods employed will provide precision, breadth of measurement, and range of pacing
sites superior to any other setting. The protocol will provide new and important scientific
information that will benefit not only surgical patients but also the general population of
BiVP recipients.
Inclusion Criteria:
- LV ejection fraction < 41%
- QRS duration > 99 msec
Or:
- Mitral and Aortic Valve Repair or Replacement
Exclusion Criteria:
- Congenital Heart Disease
- Intracardiac Shunts
- Preoperative Pacing for Heart Block (2nd or 3rd degree) or Sinus Bradycardia
- Heart Rate > 120 beats per min after Cardiopulmonary Bypass
- Preoperative Atrial Fibrillation
- Previous Cardiac Surgery
- Inability to undergo biventricular pacing prior to randomization
We found this trial at
1
site
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
Click here to add this to my saved trials
