Optimized Biventricular Pacing Allograft Recipients



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2007
End Date:March 2012
Contact:Henry M Spotnitz, MD
Email:hms2@columbia.edu
Phone:212-305-6191

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Optimized Biventricular Pacing in Allograft Recipients


This study tests optimization of biventricular pacing (BiVP) in patients with dilated
cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in
patients with advanced cardiac failure. It examines the effects of atrioventricular delay
(AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on
cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an
identical heart rate.


This study is designed to increase the benefit of biventricular pacing (BiVP), which is an
established therapy for advanced heart failure. The investigators will test 6 left
ventricular (LV) pacing sites and 16 timing sequences in the operating room just before
cardiac transplant. Pacing will be implemented after patients have been anticoagulated and
connected to the heart-lung machine. Pacing by previously implanted pacemakers will be
suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP),
left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and
simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE)
during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal
is to prove that this optimization will increase the amount of blood pumped by the failing
heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5
minutes in duration, and the entire protocol should be executable in 20 minutes. Care will
not be altered otherwise. Results will improve management of the general population of
patients with advanced heart failure while minimally increasing the risk to patients
undergoing cardiac transplantation. Benefits of this study should include: improved patient
selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP
nonresponders.

Inclusion Criteria:

- New York Heart Association (NYHA) heart failure class III/IV

- Left Ventricular Ejection Fraction (LVEF) <36%

- QRS >120 msec

Exclusion Criteria:

- Intracardiac shunts

- Sinus tachycardia >120 bpm

- Second or third degree heart block

- Previous cardiac surgery

- Mechanical circulatory assistance

- Atrial fibrillation
We found this trial at
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New York, New York 10032
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