Optimized Biventricular Pacing Allograft Recipients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-03-31

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.

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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.

Conditions

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Dilated Cardiomyopathy Ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BiVP Pacing

BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.

Group Type EXPERIMENTAL

BiVP

Intervention Type DEVICE

Biventricular pacing

AAI Pacing

Traditional atrial (AAI) pacing

Group Type ACTIVE_COMPARATOR

AAI Pacing

Intervention Type DEVICE

Atrial pacing

Interventions

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BiVP

Biventricular pacing

Intervention Type DEVICE

AAI Pacing

Atrial pacing

Intervention Type DEVICE

Other Intervention Names

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Biventricular Pacing Atrial Pacing

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No