NCT03084978

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

January 25, 2017

Last Update Submit

June 12, 2019

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of patients with serious adverse events

    within 30 days

  • Length of stay

    within 30 days

  • Readmissions

    within 30 days

  • Number of Patients with Valve Complications

    within 30 days

  • Contrast usage

    <1 day

  • +1 more secondary outcomes

Other Outcomes (2)

  • Post-procedure Complications

    within 30 days

  • Quality of Life

    Procedure start to 30 days

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

Subjects will undergo general anesthesia with endotracheal intubation.

Procedure: General Anesthesia

Conscious Sedation

EXPERIMENTAL

Subjects will undergo conscious sedation anesthesia.

Procedure: Conscious Sedation

Interventions

General AnesthesiaPROCEDURE

General anesthesia by standard endotracheal intubation.

General Anesthesia
Conscious SedationPROCEDURE

Conscious sedation

Conscious Sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26892451BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Anesthesia, GeneralConscious Sedation

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Joseph DeRose, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

March 21, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share