Optimized Biventricular Pacing Allograft Recipients (BiBET)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dilated Cardiomyopathy Ischemic Cardiomyopathy |
Device: BiVP Device: AAI Pacing |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Optimized Biventricular Pacing in Allograft Recipients |
- Cardiac Output [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.
- Atrial Latency [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
- interatrial delay (between right atrium and left atrium) [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
- Peak LV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
- Peak RV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
- Interventricular Synchrony [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BiVP Pacing
BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.
|
Device: BiVP
Biventricular pacing
Other Name: Biventricular Pacing
|
|
Active Comparator: AAI Pacing
Traditional atrial (AAI) pacing
|
Device: AAI Pacing
Atrial pacing
Other Name: Atrial Pacing
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Columbia University Medial Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Henry M Spotnitz, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Henry M. Spotnitz, George H. Humphreys, II Professor of Surgery, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01290822 History of Changes |
| Other Study ID Numbers: | AAAC1492, 1R01HL080152-01A2 |
| Study First Received: | February 2, 2011 |
| Last Updated: | September 29, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Biventricular pacing Dilated Cardiomyopathy Ischemic Cardiomyopathy Congestive heart failure Cardiac allograft |
Cardiac surgery AVD VVD LV pacing site pacing optimization |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Ischemia Cardiomyopathies Cardiomegaly |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013