Optimized Biventricular Pacing Allograft Recipients (BiBET)

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.

Study Overview

• Status: Terminated
• Conditions: Dilated Cardiomyopathy; Ischemic Cardiomyopathy
• Intervention / Treatment: Device: BiVP; Device: AAI Pacing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henry M. Spotnitz
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Henry M Spotnitz, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dilated Cardiomyopathy; Cardiac surgery; Ischemic Cardiomyopathy; Congestive heart failure; Biventricular pacing; AVD; Cardiac allograft; VVD; LV pacing site; pacing optimization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: AAAC1492; 1R01HL080152-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided