Recruiting
Phase 1

Carbon Dioxide & Saline

Sponsor:

University Health Network, Toronto

Code:

NCT03998631

Conditions

Thoracic Aortic Aneurysm

Aortic Stenosis Symptomatic

Stroke, Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carbon Dioxide and Saline Flush

Standard Saline Flush

Study Details

Brief summary:

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.

Conditions

Thoracic Aortic Aneurysm

Aortic Stenosis Symptomatic

Stroke, Complication

Study ID

NCT03998631

Start date

Jul 20, 2019

Status verified date

Sep, 2020

Completion date

Mar 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Elective TEVAR or TAVI
  • Over 18 years old

Exclusion Criteria:

  • Recent acute myocardial infarction
  • Recent stroke or TIA
  • Post or pending organ transplantation
  • Active peptic ulcer disease
  • Recent gastrointestinal bleed
  • History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy.
  • Permanent pacemaker or ICD
  • History of atrial fibrillation
  • Moderate or severe allergy to iodinated contrast not amenable to predmedication
  • Renal failure
  • Unable to safely undergo MRI
  • Enrollment in another study

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Saline Flush

This is the control arm. The TEVAR or TAVI device will be flushed with at least 60mL of standard saline to reduce bubbles in the reservoir prior to deployment. This is the standard of care.

experimental: Carbon Dioxide and Saline Flush

Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.

Interventions

Carbon Dioxide and Saline Flush

The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.

Standard Saline Flush

Standard of care flushing of the TEVAR or TAVI device with normal saline.

Primary outcome measure

  • Complications [ Time Frame: 30 days ]
  • All cause mortality [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Kong Teng Tan, MD, FRCPC

416-340-4800kongteng.tan@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Kong Teng Tan, MD

416 340-3111

Principal Investigator:

Kong Teng Tan, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 23, 2020

Last verified

Sep, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2020-09-23.