Biventricular Pacing After Cardiopulmonary Bypass

Heart Failure Clinical Trial

— BIPACS  

Official title:

Biventricular Pacing After Cardiopulmonary Bypass

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00498940
• Other study ID #: AAAB5600
• Secondary ID: R01HL080152
• Status: Terminated
• Phase: N/A
• First received: July 9, 2007
• Last updated: January 23, 2018
• Start date: October 2006
• Est. completion date: March 2012

Study information

• Verified date: January 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• Temporary Biventricular Pacing
Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Spotnitz	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).	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.	24 hours
Secondary	Number of Subjects With Postoperative Complications	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.	30 days after surgery

External Links

•   ColumbiaDoctors - Clinical Trials Search Tool
•   Primary Endpoints of the Biventricular Pacing After Cardiac Surgery Trial - The Annals of Thoracic Surgery