Optimized Biventricular Pacing Allograft Recipients (BiBET)

Henry M. Spotnitz

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Dilated Cardiomyopathy; Ischemic Cardiomyopathy

Treatments: Device: BiVP; Device: AAI Pacing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01290822

1R01HL080152-01A2 (U.S. NIH Grant/Contract)

AAAC1492

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

BiVP Pacing

Experimental group

Description:

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

Treatment:

Device: BiVP

AAI Pacing

Active Comparator group

Description:

Traditional atrial (AAI) pacing

Treatment:

Device: AAI Pacing