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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631188
Recruitment Status : Terminated (lost nurse researcher support)
First Posted : June 29, 2012
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Enrique Pantin, 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Procedure: Minimally Invasive Aortic Valve Procedure: Minimally Invasive Aortic Valve Surgery Device: Manipulation in OR surgical technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Aortic Valve Replacement
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
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.

Procedure: 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
Other Name: AVR, Mini AVR, Minimally invasive Port Access Surgery

Device: Manipulation in OR surgical technique
Endovent and pacing wire when coming off cardiopulmonary bypass
Other Name: AVR, mini avr,




Primary Outcome Measures :
  1. Safety [ Time Frame: Immediate ]
    Heart to begin pacing upon passing the wire through the catheter to the heart. the measure would be to be able to pace the heart post heart surgery.

  2. Pacing of the heart [ Time Frame: Immediatelly ]
    To be able to pace the heart post aortic valve replacement surgery


Secondary Outcome Measures :
  1. Hemodynamic Measures [ Time Frame: Immediately after intervention ]
    Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631188


Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Enrique L Pantin, MD Rutgers, The State University of New Jersey
Study Director: Jonathan Kraidin, MD Rutgers, The State University of New Jersey
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Responsible Party: Enrique Pantin, Professor, Department of Anesthesiology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01631188    
Other Study ID Numbers: 0220110241
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Enrique Pantin, Rutgers, The State University of New Jersey:
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
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