Brief Summary
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
Brief Title
Conscious Sedation vs General Anesthesia in TAVR Patients
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
Exclusion Criteria:
1. BMI \> 40
2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr.
3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
4. Inability to lie supine for more than 30 minutes.
5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
6. Patient refusal
7. Patient involved in another research study
8. Psychiatric condition precluding ability to provide informed consent
9. History of clinical stroke within 3 months prior to randomization
1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
Exclusion Criteria:
1. BMI \> 40
2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr.
3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
4. Inability to lie supine for more than 30 minutes.
5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
6. Patient refusal
7. Patient involved in another research study
8. Psychiatric condition precluding ability to provide informed consent
9. History of clinical stroke within 3 months prior to randomization
Inclusion Criteria
Inclusion Criteria:
1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03084978
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-7021
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
Primary Outcomes
Outcome Description
* time to patient on table to surgical drapes down
* time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
* time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
Outcome Measure
Time-on-table
Outcome Time Frame
<1 day
Secondary Outcomes
Outcome Description
* deaths
* conversion from sedation to intubation
* hypersensitivity reactions
* conversion from sedation to intubation
* hypersensitivity reactions
Outcome Time Frame
within 30 days
Outcome Measure
Number of patients with serious adverse events
Outcome Description
* ICU length of stay (days)
* Hospital length of stay (days)
* Hospital length of stay (days)
Outcome Time Frame
within 30 days
Outcome Measure
Length of stay
Outcome Description
Number of patients readmitted within 30 days of initial procedure
Outcome Time Frame
within 30 days
Outcome Measure
Readmissions
Outcome Description
* paravalvular leak on echocardiogram
* pacemaker requirement
* vascular complications requiring reintervention
* post-procedure requiring valve dilation
* pacemaker requirement
* vascular complications requiring reintervention
* post-procedure requiring valve dilation
Outcome Time Frame
within 30 days
Outcome Measure
Number of Patients with Valve Complications
Outcome Description
Amount of contrast used in mL for procedure
Outcome Time Frame
<1 day
Outcome Measure
Contrast usage
Outcome Description
Amount of time fluoroscopy used
Outcome Time Frame
<1 day
Outcome Measure
Fluoroscopy time
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Derose
Investigator Email
joseph.derose@einsteinmed.org
Investigator Phone