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

Not Applicable

Terminated

• Conditions: Aortic Valve Disease
• Interventions: Procedure: Minimally Invasive Aortic Valve; Procedure: Minimally Invasive Aortic Valve Surgery; Device: Manipulation in OR surgical technique

• Registration Number: NCT01631188
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-29
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2021-05-03
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Results First Posted: 2021-11-16
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aortic Valve Replacement	Minimally Invasive Aortic Valve	During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.
Aortic Valve Replacement	Manipulation in OR surgical technique	During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.
Aortic Valve Replacement	Minimally Invasive Aortic Valve Surgery	During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Required Pacing Who Were Able to be Paced	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.	To be able to pace the heart post aortic valve replacement surgery
Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent	Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.	Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs