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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01631188
First received: March 12, 2012
Last updated: November 13, 2013
Last verified: April 2013
  Purpose

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 Intervention
Aortic Valve Disease
Procedure: Minimally Invasive Aortic Valve
Procedure: Minimally Invasive Aortic Valve Surgery
Device: Manipulation in OR surgical technique

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Safety [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
    Heart to begin pacing upon passing the wire through the catheter to the heart


Secondary Outcome Measures:
  • Hemodynamic Measures [ Time Frame: Immediately after intervention ] [ Designated as safety issue: Yes ]
    Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631188

Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01631188     History of Changes
Other Study ID Numbers: 0220110241
Study First Received: March 12, 2012
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Edwards Lifesciences

ClinicalTrials.gov processed this record on April 15, 2014