Biventricular Pacing After Cardiopulmonary Bypass (BIPACS)

This study has been terminated.
(Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier:
NCT00498940
First received: July 9, 2007
Last updated: May 11, 2012
Last verified: May 2012

July 9, 2007
May 11, 2012
October 2006
March 2012   (final data collection date for primary outcome measure)
The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00498940 on ClinicalTrials.gov Archive Site
Secondary end points include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
Secondary end points include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. [ Time Frame: 30 days after surgery ]
Not Provided
Not Provided
 
Biventricular Pacing After Cardiopulmonary Bypass
Biventricular Pacing After Cardiopulmonary Bypass

The purpose of this study is to investigate the efficacy of optimized temporary biventricular pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and an intraventricular conduction delay. This study will compare extended temporary biventricular pacing versus standard of care by assessing patients randomized to the two groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic circulatory support in the intensive care unit. In addition, effects of biventricular pacing will be tested in all patients, at three time points, using different measures of blood flow. Results from this research will demonstrate whether temporary BiVP improves cardiac output after open-heart surgery and whether ventricular pacing optimization increases cardiac output in this setting. Success would lead to the development of recommendations for use of BiVP postoperatively and would stimulate the development of pacemakers with appropriate features. Our primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index (CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining POPT at three time points within 24 hours of surgery. We will examine which forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures of perfusion and cardiac function. We will also analyze survival, length of stay, incidence of arrhythmias, and cost of postoperative care.

Biventricular pacing (BiVP) reverses intraventricular conduction delay (IVCD) and left ventricular (LV) dysfunction in dilated cardiomyopathy (DCM). BiVP improves LV function and cardiac index (Cl) at no energy cost. In the MIRACLE trial, in patients with DCM, IVCD and LV ejection fraction <35%, demonstrated improved subjective and objective measures of exercise tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not fully developed, and 30% of recipients are "nonresponders," at a cost of more than $2 billion/year. Preliminary data suggest that BiVP can benefit patients with low output states after cardiac surgery. We plan to assess surgical application of BiVP while assessing mechanisms of action and optimization. We will randomize 190 cardiac surgery patients with LV dysfunction preoperatively to paced and standard of care groups. BiVP will be optimized and continued postoperatively until patients are stable. BiVP will be assessed transiently in all patients at three time points. The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). Effects of heart rate, atrioventricular delay, ventricular pacing site, and interventricular delay on Cl will be assessed using a randomized sequence of data collection. Secondary endpoints include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. These studies are important because of a high probability of clinical benefit. The methods employed will provide precision, breadth of measurement, and range of pacing sites superior to any other setting. The protocol will provide new and important scientific information that will benefit not only surgical patients but also the general population of BiVP recipients.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Temporary Biventricular Pacing
Pacing Optimization tested at three time points for both arms. Continuous temporary biventricular pacing for 24 hours in experimental group only.
Other Name: Medtronic Insync III
  • Experimental: POPT
    Temporary Biventricular Pacing
    Intervention: Device: Temporary Biventricular Pacing
  • No Intervention: Standard of Care
    Control Group - Intermittent biventricular pacing tested for optimization only.
    Intervention: Device: Temporary Biventricular Pacing
Rubinstein BJ, Wang DY, Cabreriza SE, Cheng B, Aponte-Patel L, Murata A, Rusanov A, Richmond ME, Quinn TA, Spotnitz HM. Response of mean arterial pressure to temporary biventricular pacing after chest closure during cardiac surgery. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1445-52. doi: 10.1016/j.jtcvs.2012.04.026. Epub 2012 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
114
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • LV ejection fraction < 41%
  • QRS duration > 99 msec

Or:

  • Mitral and Aortic Valve Repair or Replacement

Exclusion Criteria:

  • Congenital Heart Disease
  • Intracardiac Shunts
  • Preoperative Pacing for Heart Block (2nd or 3rd degree) or Sinus Bradycardia
  • Heart Rate > 120 beats per min after Cardiopulmonary Bypass
  • Preoperative Atrial Fibrillation
  • Previous Cardiac Surgery
  • Inability to undergo biventricular pacing prior to randomization
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498940
AAAB5600, R01HL080152
Yes
Henry M. Spotnitz, Columbia University
Henry M. Spotnitz
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Henry M. Spotnitz, M.D. Professor
Columbia University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP