Trial Outcomes & Findings for Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery (NCT NCT01631188)
NCT ID: NCT01631188
Last Updated: 2021-11-16
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Results posted on
2021-11-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
75
|
Baseline Characteristics
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Baseline characteristics by cohort
| Measure |
Aortic Valve Replacement
n=25 Participants
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
|
|---|---|
|
Age, Continuous
|
74.92 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.Population: 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.
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
Outcome measures
| Measure |
Aortic Valve Replacement
n=23 Participants
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
|
|---|---|
|
Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
|
23 Participants
|
PRIMARY outcome
Timeframe: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.To be able to pace the heart post aortic valve replacement surgery
Outcome measures
| Measure |
Aortic Valve Replacement
n=12 Participants
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
|
|---|---|
|
Number of Participants That Required Pacing Who Were Able to be Paced
|
12 Participants
|
SECONDARY outcome
Timeframe: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.Population: 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.
Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs
Outcome measures
| Measure |
Aortic Valve Replacement
n=23 Participants
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
|
|---|---|
|
Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Participant with arrhythmia not requiring intervention
|
5 Participants
|
|
Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Participant with arrhythmia requiring intervention
|
1 Participants
|
Adverse Events
Aortic Valve Replacement
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aortic Valve Replacement
n=23 participants at risk
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
|
|---|---|
|
Cardiac disorders
hypotension
|
4.3%
1/23
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place