Optimized Biventricular Pacing Allograft Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimized Biventricular Pacing in Allograft Recipients

Conditions
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Dilated Cardiomyopathy, Ischemic Cardiomyopathy

Intervention / Treatment
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* Device: BiVP
* Device: AAI Pacing


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiVP Pacing<br>BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output. | Device: BiVP<br>* Biventricular pacing<br>* Other names: Biventricular Pacing;|
| Active Comparator: AAI Pacing<br>Traditional atrial (AAI) pacing | Device: AAI Pacing<br>* Atrial pacing<br>* Other names: Atrial Pacing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output | The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately. | 13 minutes of testing; performed before CPB for allograft receipt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Latency |  | 13 minutes of testing; performed before CPB for allograft receipt | 
| Interatrial Delay (Between Right Atrium and Left Atrium) | Results could not be analyzed due to poor enrollment and lack of data. | 13 minutes of testing; performed before CPB for allograft receipt | 
| Peak LV dP/dt |  | 13 minutes of testing; performed before CPB for allograft receipt | 
| Peak RV dP/dt |  | 13 minutes of testing; performed before CPB for allograft receipt | 
| Interventricular Synchrony |  | 13 minutes of testing; performed before CPB for allograft receipt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biventricular pacing, Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Congestive heart failure, Cardiac allograft, Cardiac surgery, AVD, VVD, LV pacing site, pacing optimization