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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01631188
• Other study ID #: 0220110241
• Status: Terminated
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >= 18 years of age patients having aortic valve port access surgery

Scheduled for Minimally Invasive Port Access Aortic Valve Study

Patient must agree to study participation; understand and sign the written informed consent

Exclusion Criteria:

• < 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Procedure:
• Minimally Invasive Aortic Valve
Patients 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.
• Minimally Invasive Aortic Valve Surgery
The 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

Device:
• Manipulation in OR surgical technique
Endovent and pacing wire when coming off cardiopulmonary bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal	Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Primary	Number of Participants That Required Pacing Who Were Able to be Paced	To be able to pace the heart post aortic valve replacement surgery	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Secondary	Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent	Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.