Clinical trial NCT01290822: Optimized Biventricular Pacing Allograft Recipients
Official title: Optimized Biventricular Pacing in Allograft Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-02-07
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Cardiac Output
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
Secondary outcomes:
measure: Atrial Latency
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
measure: Interatrial Delay (Between Right Atrium and Left Atrium)
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
measure: Peak LV dP/dt
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
measure: Peak RV dP/dt
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
measure: Interventricular Synchrony
timeFrame: 13 minutes of testing; performed before CPB for allograft receipt
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medial Center
state: New York
Study officials:
affiliation: Columbia University
name: Henry M Spotnitz, MD
role: PRINCIPAL_INVESTIGATOR
References: