Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
lost nurse researcher support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent | 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. |
Not provided
Inclusion Criteria:
Scheduled for Minimally Invasive Port Access Aortic Valve Study
Patient must agree to study participation; understand and sign the written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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 Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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 Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 23 patients were analyzed. Patient # 12 (male, 75 year) and # 19 (male, 61 year) were eliminated from the study after an intraoperative TEE showed additional pathology that changed the operation needed, and thus the operation from a "mini AVR" to a full sternotomy eliminating the need for the study Endovent pacing lead. | Posted | Count of Participants | Participants | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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 Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | 1 patient of 23 had an episode wide complex QRS vs slow ventricular tachycardia with concurrent drop of systolic blood pressure to 60's that was terminated (arrhythmia and hypotension) by withdrawing the pacing wire back into the Endovent catheter. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Pantin, MD | Rutgers University | 7328900640 | pantinej@rwmjs.rutgers.edu |
Not provided
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
|
| Manipulation in OR surgical technique | Device | Endovent and pacing wire when coming off cardiopulmonary bypass |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants That Required Pacing Who Were Able to be Paced | To be able to pace the heart post aortic valve replacement surgery | Posted | Count of Participants | Participants | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. |
|
|
|
| Secondary | Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent | Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs | 1 of 6 had hemodynamic disturbances significant enough to act immediately. Subject had PVC's, run of wide complex QRS with concurrent drop of systolic blood pressure to 60's, the pacing wire was pulled out of the ventricle, and blood pressure was restored and arrhythmia disappeared. | Posted | Count of Participants | Participants | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. |
|
|
|
| 1 |
| 23 |
| 0 |
| 23 |
|
Not provided
Not provided
Not provided