NCT01987531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

November 5, 2013

Last Update Submit

November 10, 2017

Conditions

Right Ventricular (RV) Dysfunction

Keywords

after open cardiac chamber cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Right ventricular function of the heart

    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

Study Arms (1)

left ventricular epicardial pacing lead

EXPERIMENTAL

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

Interventions

left ventricular epicardial pacing leadOTHER
left ventricular epicardial pacing lead

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • William Vernick, MD

    University of Pennsylvania, Anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 19, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

US(1)