Optimized Biventricular Pacing Allograft Recipients

Dilated Cardiomyopathy Clinical Trial

— BiBET  

Official title:

Optimized Biventricular Pacing in Allograft Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01290822
• Other study ID #: AAAC1492
• Secondary ID: 1R01HL080152-01A
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 2, 2011
• Last updated: October 11, 2013
• Start date: January 2007
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Ischemic Cardiomyopathy

Intervention

Device:
• BiVP
Biventricular pacing
• AAI Pacing
Atrial pacing

Locations

Country	Name	City	State
United States	Columbia University Medial Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Spotnitz	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Atrial Latency		13 minutes of testing; performed before CPB for allograft receipt	No
Secondary	interatrial delay (between right atrium and left atrium)		13 minutes of testing; performed before CPB for allograft receipt	No
Secondary	Peak LV dP/dt		13 minutes of testing; performed before CPB for allograft receipt	No
Secondary	Peak RV dP/dt		13 minutes of testing; performed before CPB for allograft receipt	No
Secondary	Interventricular Synchrony		13 minutes of testing; performed before CPB for allograft receipt	No