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

November 15, 2021 updated by: Enrique Pantin, Rutgers, The State University of New Jersey
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • AVR, Mini AVR, Minimally invasive Port Access Surgery
Device: Manipulation in OR surgical technique
Endovent and pacing wire when coming off cardiopulmonary bypass
Other Names:
  • AVR, mini avr,

What is the study measuring?

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
Time Frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
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
Time Frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
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
Time Frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0220110241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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