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

• ClinicalTrials.gov Identifier: NCT01631188
• Recruitment Status: Terminated
• First Posted: June 29, 2012
• Last Update Posted: July 30, 2019
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Enrique Pantin, Rutgers, The State University of New Jersey

Study Description

Brief Summary:

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 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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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

Arms and Interventions

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 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,

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Pacing of the heart [ Time Frame: Immediatelly ]
   To be able to pace the heart post aortic valve replacement surgery

Secondary Outcome Measures :

1. Hemodynamic Measures [ Time Frame: Immediately after intervention ]
   Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Enrique Pantin, Professor, Department of Anesthesiology, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT01631188
• Other Study ID Numbers: 0220110241
• First Posted: June 29, 2012
• Last Update Posted: July 30, 2019
• Last Verified: July 2019

Keywords provided by Enrique Pantin, 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