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: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Optimization Testing
Device: Temporary Biventricular 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: Treatment
Official Title: Biventricular Pacing After Cardiopulmonary Bypass

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 111
Study Start Date: October 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: Standard of Care
No continuous pacing occurred about surgery. Patients underwent optimization testing.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498940

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Henry M. Spotnitz
Investigators
Principal Investigator: Henry M. Spotnitz, M.D. Professor
  More Information

Additional Information:
No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry M. Spotnitz, George H. Humphreys, II Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT00498940     History of Changes
Other Study ID Numbers: AAAB5600, R01HL080152
Study First Received: July 9, 2007
Results First Received: February 3, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
LV function, Compliance, wall motion, echocardiography

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014