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

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Aortic Valve Disease

Treatments: Procedure: Minimally Invasive Aortic Valve Surgery; Procedure: Minimally Invasive Aortic Valve; Device: Manipulation in OR surgical technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01631188

0220110241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Aortic Valve Replacement

Experimental group

Description:

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.

Treatment:

Procedure: Minimally Invasive Aortic Valve

Device: Manipulation in OR surgical technique

Procedure: Minimally Invasive Aortic Valve Surgery