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Temporary Biventricular Pacing (BIPACE)

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.
 
ClinicalTrials.gov Identifier: NCT01987531
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery.

Condition or disease Intervention/treatment Phase
Right Ventricular (RV) Dysfunction Other: left ventricular epicardial pacing lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Effect of Temporary Biventricular Pacing After Mitral and/or Tricuspid Valve Surgery in Patients With Preoperative Biventricular Dysfunction
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: left ventricular epicardial pacing lead
Enrolled patients will have a temporary left ventricular epicardial pacing lead placed in addition to the standard right ventricular and right atrial temporary epicardial pacing leads after open cardiac chamber cardiac surgery.
Other: left ventricular epicardial pacing lead



Primary Outcome Measures :
  1. Right ventricular function of the heart [ Time Frame: 24 hours after cardiac surgery completion ]
    Right Ventricular function is evaluated through combined echocardiographic interventricular synchrony variables which include pulmonary artery catheter derived cardiac index, pulmonary artery (PA) pressure, central venous pressure (CVP), CVP versus PA diastolic pressure, and systolic blood pressure.



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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mitral or tricuspid valve surgery patients identified as having preoperative Right Ventricular dysfunction and Left Ventricular Ejection Fraction less than 45 percent

Exclusion Criteria:

  • Patients with in-situ biventricular pacemakers
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987531


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: William Vernick, MD University of Pennsylvania, Anesthesia
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01987531    
Other Study ID Numbers: 816482
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by University of Pennsylvania:
after open cardiac chamber cardiac surgery