Biventricular Pacing After Cardiopulmonary Bypass (BIPACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498940
Recruitment Status : Terminated (Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III)
First Posted : July 11, 2007
Results First Posted : May 2, 2014
Last Update Posted : February 21, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University

July 9, 2007
July 11, 2007
February 3, 2014
May 2, 2014
February 21, 2018
October 2006
March 2012   (Final data collection date for primary outcome measure)
Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU). [ Time Frame: 24 hours ]
Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.
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 Archive Site
Number of Subjects With Postoperative Complications [ Time Frame: 30 days after surgery ]
This is to measure the total number of subjects that experienced any of the following complications: sepsis/infection, renal failure, respiratory failure/complications, bleeding requiring reoperation, cerebrovascular accident.
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.

The 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. The investigator will examine which forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures of perfusion and cardiac function. The investigator 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. This study will assess surgical application of BiVP while assessing mechanisms of action and optimization. 190 cardiac surgery patients will be randomized 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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
  • Device: Optimization Testing
    Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
    Other Name: Medtronic Insync III
  • Device: Temporary Biventricular Pacing
    Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.
  • Active Comparator: Biventricular Pacing
    After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).
    • Device: Optimization Testing
    • Device: Temporary Biventricular Pacing
  • Active Comparator: Standard of Care
    No continuous pacing occurred about surgery. Patients underwent optimization testing.
    Intervention: Device: Optimization Testing
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 Identifier (NCT Number) in Medline.
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01HL080152 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Not Provided
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
January 2018

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