Optimized Biventricular Pacing Allograft Recipients

Optimized Biventricular Pacing in Allograft Recipients

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01290822

Acronym

BiBET

Enrollment

Registered

2011-02-07

Start date

2007-01-31

Completion date

2011-03-31

Last updated

2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy, Ischemic Cardiomyopathy

Keywords

Biventricular pacing, Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Congestive heart failure, Cardiac allograft, Cardiac surgery, AVD, VVD, LV pacing site, pacing optimization

Brief summary

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

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.

Interventions

DEVICEBiVP

Biventricular pacing

DEVICEAAI Pacing

Atrial pacing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Atrial Latency	13 minutes of testing; performed before CPB for allograft receipt	—
Interatrial Delay (Between Right Atrium and Left Atrium)	13 minutes of testing; performed before CPB for allograft receipt	Results could not be analyzed due to poor enrollment and lack of data.
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	—

Countries

United States

Participant flow

Recruitment details

Data could not be analyzed due to poor enrollment and lack of data. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.

Participants by arm

Arm	Count
All Subjects in the Study This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.	12
Total	12

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	10
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	All Subjects in the Study
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	4 Participants
Age, Categorical Between 18 and 65 years	8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	5 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	6 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

Cardiac Output

The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.