Optimized Biventricular Pacing Allograft Recipients
- Conditions
- Dilated CardiomyopathyIschemic Cardiomyopathy
- Interventions
- Device: BiVPDevice: AAI Pacing
- Registration Number
- NCT01290822
- Lead Sponsor
- Henry M. Spotnitz
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- New York Heart Association (NYHA) heart failure class III/IV
- Left Ventricular Ejection Fraction (LVEF) <36%
- QRS >120 msec
- Intracardiac shunts
- Sinus tachycardia >120 bpm
- Second or third degree heart block
- Previous cardiac surgery
- Mechanical circulatory assistance
- Atrial fibrillation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BiVP Pacing BiVP BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output. AAI Pacing AAI Pacing Traditional atrial (AAI) pacing
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Columbia University Medial Center
🇺🇸New York, New York, United States