Biventricular Pacing After Cardiopulmonary Bypass

NCT00498940 | Terminated Results DMC FDA Device

• 2 other identifiers: AAAB5600R01HL080152
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

LV function, Compliance, wall motion, echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Subjects With Postoperative Complications

  30 days after surgery

Study Arms (2)

Biventricular Pacing

ACTIVE COMPARATOR

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

Standard of Care

ACTIVE COMPARATOR

No continuous pacing occurred about surgery. Patients underwent optimization testing.

Device: Optimization Testing

Interventions

Optimization Testing DEVICE

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.

Also known as: Medtronic Insync III

Biventricular Pacing; Standard of Care

Temporary Biventricular Pacing DEVICE

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

Biventricular Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LV ejection fraction \< 41%
• QRS duration \> 99 msec
• Or:
• Mitral and Aortic Valve Repair or Replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Spotnitz: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 22920599 DERIVED

Related Links

• ColumbiaDoctors - Clinical Trials Search Tool

MeSH Terms

Conditions

Heart Failure; Patient Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Santos Cabreriza/ Associate Scientist
• Organization: Columbia University Medical Center

sc45@cumc.columbia.edu

212-305-9515

Study Officials

• Henry M. Spotnitz, M.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: George H. Humphreys, II Professor of Surgery

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 22, 2018
• Results First Posted: May 2, 2014

Record last verified: 2018-01

Locations

US (1)