Clinical Trials Directory

Trials / Terminated

TerminatedNCT01631188

Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Rutgers, The State University of New Jersey · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system.

Detailed description

Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.

Conditions

Interventions

TypeNameDescription
PROCEDUREMinimally Invasive Aortic ValvePatients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.
PROCEDUREMinimally Invasive Aortic Valve SurgeryThe Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine
DEVICEManipulation in OR surgical techniqueEndovent and pacing wire when coming off cardiopulmonary bypass

Timeline

Start date
2011-12-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2012-06-29
Last updated
2021-11-16
Results posted
2021-11-16

Source: ClinicalTrials.gov record NCT01631188. Inclusion in this directory is not an endorsement.