Conscious Sedation vs General Anesthesia in TAVR Patients

Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time

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.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Stenosis
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Conscious Sedation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia; Subjects will undergo general anesthesia with endotracheal intubation.	Procedure: General Anesthesia; General anesthesia by standard endotracheal intubation.
Experimental: Conscious Sedation; Subjects will undergo conscious sedation anesthesia.	Procedure: Conscious Sedation; Conscious sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	<1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with serious adverse events	deaths; conversion from sedation to intubation; hypersensitivity reactions	within 30 days
Length of stay	ICU length of stay (days); Hospital length of stay (days)	within 30 days
Readmissions	Number of patients readmitted within 30 days of initial procedure	within 30 days
Number of Patients with Valve Complications	paravalvular leak on echocardiogram; pacemaker requirement; vascular complications requiring reintervention; post-procedure requiring valve dilation	within 30 days
Contrast usage	Amount of contrast used in mL for procedure	<1 day
Fluoroscopy time	Amount of time fluoroscopy used	<1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-procedure Complications	TIA or Stroke; Myocardial Infarction; Bleeding; Infection	within 30 days
Quality of Life	Kansas City Cardiomyopathy Questionnaire at 30 days	Procedure start to 30 days

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Joseph DeRose, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2016-7021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No