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

NCT ID: NCT01631188

Last Updated: 2021-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Aortic Valve Disease

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Minimally Invasive Aortic Valve

Intervention Type PROCEDURE

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.

Minimally Invasive Aortic Valve Surgery

Intervention Type PROCEDURE

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

Manipulation in OR surgical technique

Intervention Type DEVICE

Endovent and pacing wire when coming off cardiopulmonary bypass

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Manipulation in OR surgical technique

Endovent and pacing wire when coming off cardiopulmonary bypass

Intervention Type DEVICE

Other Intervention Names

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AVR, Mini AVR, Minimally invasive Port Access Surgery AVR, mini avr,

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Enrique Pantin

Professor, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique L Pantin, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Jonathan Kraidin, MD

Role: STUDY_DIRECTOR

Rutgers, The State University of New Jersey

Other Identifiers

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0220110241

Identifier Type: -

Identifier Source: org_study_id