NCT03998631

Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Standard Saline Flush	Standard of care flushing of the TEVAR or TAVI device with normal saline.

Timeline

• Start date: 2019-07-20
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2019-06-26
• Last updated: 2020-09-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study