Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
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|ClinicalTrials.gov Identifier: NCT01631188|
Recruitment Status : Terminated (lost nurse researcher support)
First Posted : June 29, 2012
Last Update Posted : July 30, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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,
- 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.
- Pacing of the heart [ Time Frame: Immediatelly ]To be able to pace the heart post aortic valve replacement surgery
- Hemodynamic Measures [ Time Frame: Immediately after intervention ]Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs
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
|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|