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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Procedure: Minimally Invasive Aortic Valve
* Procedure: Minimally Invasive Aortic Valve Surgery
* Device: Manipulation in OR surgical technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aortic Valve Replacement<br>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. | Procedure: Minimally Invasive Aortic Valve<br>* 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.<br>Procedure: Minimally Invasive Aortic Valve Surgery<br>* 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<br>* Other names: AVR, Mini AVR, Minimally invasive Port Access Surgery;Device: Manipulation in OR surgical technique<br>* Endovent and pacing wire when coming off cardiopulmonary bypass<br>* Other names: AVR, mini avr,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Surgery, Port Access Surgery, Heart, Pacing, Wire, MICS, Cardiac Bypass, Epicardial pacing, pacing catheter, pacing wire, pacing swan, pacing pulmonary catheter, Pulmonary Endovent, Catheter, Aortic Valve Surgery, Edwards Lifesciences