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Optimized Biventricular Pacing Allograft Recipients (BiBET)

Primary Purpose

Dilated Cardiomyopathy, Ischemic Cardiomyopathy

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BiVP

AAI Pacing

About this trial

This is an interventional supportive care trial for Dilated Cardiomyopathy focused on measuring Biventricular pacing, Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Congestive heart failure, Cardiac allograft, Cardiac surgery, AVD, VVD, LV pacing site, pacing optimization

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

Sites / Locations

Columbia University Medial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiVP Pacing

AAI Pacing

Arm Description

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

Traditional atrial (AAI) pacing

Outcomes

Primary Outcome Measures

Cardiac Output

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

Secondary Outcome Measures

Atrial Latency

Interatrial Delay (Between Right Atrium and Left Atrium)

Results could not be analyzed due to poor enrollment and lack of data.

Peak LV dP/dt

Peak RV dP/dt

Interventricular Synchrony

Full Information

NCT ID

NCT01290822

First Posted

February 2, 2011

Last Updated

August 25, 2016

Sponsor

Henry M. Spotnitz

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01290822

Brief Title

Optimized Biventricular Pacing Allograft Recipients

Acronym

BiBET

Official Title

Optimized Biventricular Pacing in Allograft Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual and anticipated loss of funding

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henry M. Spotnitz

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BiVP Pacing

Arm Type

Experimental

Arm Description

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

Arm Title

AAI Pacing

Arm Type

Active Comparator

Arm Description

Traditional atrial (AAI) pacing

Intervention Type

Device

Intervention Name(s)

BiVP

Other Intervention Name(s)

Biventricular Pacing

Intervention Description

Biventricular pacing

Intervention Type

Device

Intervention Name(s)

AAI Pacing

Other Intervention Name(s)

Atrial Pacing

Intervention Description

Atrial pacing

Primary Outcome Measure Information:

Title

Cardiac Output

Description

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

Time Frame