Temporary Biventricular Pacing (BIPACE)

November 10, 2017 updated by: University of Pennsylvania

Hemodynamic Effect of Temporary Biventricular Pacing After Mitral and/or Tricuspid Valve Surgery in Patients With Preoperative Biventricular Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after cardiac surgery completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: William Vernick, MD, University of Pennsylvania, Anesthesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 816482

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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