Back to resultsConscious Sedation vs General Anesthesia in TAVR Patients
Primary Purpose
Aortic Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
General Anesthesia
Conscious Sedation
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
- Age over 18 years of age.
- Women of child bearing age must have a negative urine or serum pregnancy test.
- Clinical indication for a transfemoral aortic valve replacement.
- English or Spanish speaking
- 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:
- BMI > 40
- Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
- High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
- Inability to lie supine for more than 30 minutes.
- Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
- Patient refusal
- Patient involved in another research study
- Psychiatric condition precluding ability to provide informed consent
- History of clinical stroke within 3 months prior to randomization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General Anesthesia
Conscious Sedation
Arm Description
Subjects will undergo general anesthesia with endotracheal intubation.
Subjects will undergo conscious sedation anesthesia.
Outcomes
Primary Outcome Measures
Time-on-table
time to patient on table to surgical drapes down
time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
Secondary Outcome Measures
Number of patients with serious adverse events
deaths
conversion from sedation to intubation
hypersensitivity reactions
Length of stay
ICU length of stay (days)
Hospital length of stay (days)
Readmissions
Number of patients readmitted within 30 days of initial procedure
Number of Patients with Valve Complications
paravalvular leak on echocardiogram
pacemaker requirement
vascular complications requiring reintervention
post-procedure requiring valve dilation
Contrast usage
Amount of contrast used in mL for procedure
Fluoroscopy time
Amount of time fluoroscopy used
Full Information
NCT ID
NCT03084978
First Posted
January 25, 2017
Last Updated
June 12, 2019
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03084978
Brief Title
Conscious Sedation vs General Anesthesia in TAVR Patients
Official Title
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never approved by the IRB
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
Subjects will undergo general anesthesia with endotracheal intubation.
Arm Title
Conscious Sedation
Arm Type
Experimental
Arm Description
Subjects will undergo conscious sedation anesthesia.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Intervention Description
General anesthesia by standard endotracheal intubation.
Intervention Type
Procedure
Intervention Name(s)
Conscious Sedation
Intervention Description
Conscious sedation
Primary Outcome Measure Information:
Title
Time-on-table
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 Frame
<1 day
Secondary Outcome Measure Information:
Title
Number of patients with serious adverse events
Description
deaths
conversion from sedation to intubation
hypersensitivity reactions
Time Frame
within 30 days
Title
Length of stay
Description
ICU length of stay (days)
Hospital length of stay (days)
Time Frame
within 30 days
Title
Readmissions
Description
Number of patients readmitted within 30 days of initial procedure
Time Frame
within 30 days
Title
Number of Patients with Valve Complications
Description
paravalvular leak on echocardiogram
pacemaker requirement
vascular complications requiring reintervention
post-procedure requiring valve dilation
Time Frame
within 30 days
Title
Contrast usage
Description
Amount of contrast used in mL for procedure
Time Frame
<1 day
Title
Fluoroscopy time
Description
Amount of time fluoroscopy used
Time Frame
<1 day
Other Pre-specified Outcome Measures:
Title
Post-procedure Complications
Description
TIA or Stroke
Myocardial Infarction
Bleeding
Infection
Time Frame
within 30 days
Title
Quality of Life
Description
Kansas City Cardiomyopathy Questionnaire at 30 days
Time Frame
Procedure start to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
Age over 18 years of age.
Women of child bearing age must have a negative urine or serum pregnancy test.
Clinical indication for a transfemoral aortic valve replacement.
English or Spanish speaking
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:
BMI > 40
Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
Inability to lie supine for more than 30 minutes.
Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
Patient refusal
Patient involved in another research study
Psychiatric condition precluding ability to provide informed consent
History of clinical stroke within 3 months prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph DeRose, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26892451
Citation
Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
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Conscious Sedation vs General Anesthesia in TAVR Patients
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