Conscious Sedation vs General Anesthesia in TAVR Patients

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03084978
• Other study ID #: 2016-7021
• Status: Withdrawn
• Phase: N/A
• Start date: April 2017
• Est. completion date: April 2019

Study information

• Verified date: June 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Procedure:
• General Anesthesia
General anesthesia by standard endotracheal intubation.
• Conscious Sedation
Conscious sedation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-procedure Complications	TIA or Stroke; Myocardial Infarction; Bleeding; Infection	within 30 days
Other	Quality of Life	Kansas City Cardiomyopathy Questionnaire at 30 days	Procedure start to 30 days
Primary	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	Number of patients with serious adverse events	deaths; conversion from sedation to intubation; hypersensitivity reactions	within 30 days
Secondary	Length of stay	ICU length of stay (days); Hospital length of stay (days)	within 30 days
Secondary	Readmissions	Number of patients readmitted within 30 days of initial procedure	within 30 days
Secondary	Number of Patients with Valve Complications	paravalvular leak on echocardiogram; pacemaker requirement; vascular complications requiring reintervention; post-procedure requiring valve dilation	within 30 days
Secondary	Contrast usage	Amount of contrast used in mL for procedure	<1 day
Secondary	Fluoroscopy time	Amount of time fluoroscopy used	<1 day