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

NCT01631188 | Terminated Results DMC

• 1 other identifier: 0220110241
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal

  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

  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 Outcomes (1)

• Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent

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

Study Arms (1)

Aortic Valve Replacement

EXPERIMENTAL

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

Interventions

Minimally Invasive Aortic Valve 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.

Aortic Valve Replacement

Minimally Invasive Aortic Valve Surgery 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

Also known as: AVR, Mini AVR, Minimally invasive Port Access Surgery

Aortic Valve Replacement

Manipulation in OR surgical technique DEVICE

Endovent and pacing wire when coming off cardiopulmonary bypass

Also known as: AVR, mini avr,

Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• \< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Enrique Pantin, MD
• Organization: Rutgers University

pantinej@rwmjs.rutgers.edu

7328900640

Study Officials

• Enrique L Pantin, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Jonathan Kraidin, MD

  Rutgers, The State University of New Jersey

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: June 29, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-11