Back to resultsUse of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Primary Purpose
Aortic Valve Disease
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally Invasive Aortic Valve
Minimally Invasive Aortic Valve Surgery
Manipulation in OR surgical technique
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Disease focused on measuring 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
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aortic Valve Replacement
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Number of Participants That Required Pacing Who Were Able to be Paced
To be able to pace the heart post aortic valve replacement surgery
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01631188
First Posted
March 12, 2012
Last Updated
November 15, 2021
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01631188
Brief Title
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Official Title
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
lost nurse researcher support
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aortic Valve Replacement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Aortic Valve
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Aortic Valve Surgery
Other Intervention Name(s)
AVR, Mini AVR, Minimally invasive Port Access Surgery
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Manipulation in OR surgical technique
Other Intervention Name(s)
AVR, mini avr,
Intervention Description
Endovent and pacing wire when coming off cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
Description
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
Time Frame
Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Title
Number of Participants That Required Pacing Who Were Able to be Paced
Description
To be able to pace the heart post aortic valve replacement surgery
Time Frame
Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Secondary Outcome Measure Information:
Title
Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Description
Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs
Time Frame
Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique L Pantin, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Kraidin, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
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