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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
Sponsored by
Henry M. Spotnitz
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 2, 2011
Last Updated
August 25, 2016
Sponsor
Henry M. Spotnitz
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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
No

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
13 minutes of testing; performed before CPB for allograft receipt
Secondary Outcome Measure Information:
Title
Atrial Latency
Time Frame
13 minutes of testing; performed before CPB for allograft receipt
Title
Interatrial Delay (Between Right Atrium and Left Atrium)
Description
Results could not be analyzed due to poor enrollment and lack of data.
Time Frame
13 minutes of testing; performed before CPB for allograft receipt
Title
Peak LV dP/dt
Time Frame
13 minutes of testing; performed before CPB for allograft receipt
Title
Peak RV dP/dt
Time Frame
13 minutes of testing; performed before CPB for allograft receipt
Title
Interventricular Synchrony
Time Frame
13 minutes of testing; performed before CPB for allograft receipt

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry M Spotnitz, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medial Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Optimized Biventricular Pacing Allograft Recipients

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