Impact of Right Atrial Occlusion on TEVAR Outcomes

Impact of Right Atrial Occlusion on TEVAR Outcomes: A Prospective Cohort Study

Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Thoracic Aorta Abnormality
• Intervention / Treatment: Procedure: Right atrial balloon occlusion; Procedure: Non right atrial balloon occlusion

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Claire Allen, MD, FRCPC; Phone Number: 403-; Email: claire.allen@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta

Description

Inclusion Criteria:

• age 18 years or older
• thoracic endovascular aortic repair
• right atrial balloon occlusion for reduction or elimination of aortic impulse
• endograft deployment in landing zones 0-3

Exclusion Criteria:

• age 18 years or younger
• non-thoracic endovascular aortic repair
• reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion
• endograft deployment in landing zones 4 and beyond

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right atrial balloon occlusion; Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse	Procedure: Right atrial balloon occlusion; Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3
Non right atrial balloon occlusion; Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse	Procedure: Non right atrial balloon occlusion; Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoleak occurrence up to hospital discharge	Endoleak occurrence prior to hospital discharge	end of surgery to hospital discharge up to 10 days)
Endoleak occurrence to one-year post-surgery	Endoleak occurrence within one-year of surgery	end of surgery to one-year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative mortality to 30 days post-surgery	30-day perioperative mortality	post-surgery to 30 days post-surgery
All-cause mortality to one-year post-surgery	One-year all-cause mortality	post-surgery to one-year post-surgery
Complications: massive hemorrhage	Occurrence of massive hemorrhage	within 30 days post-surgery and at 1 year
Complications: cerebrovascular	Occurrence of cerebrovascular accident/transient ischemic attack	within 30 days post-surgery and at 1 year
Complications: spinal cord ischemia	Occurrence of spinal cord ischemia	within 30 days post-surgery and at 1 year
Complications: iliofemoral access	Occurrence of iliofemoral access complications (bleeding/infection/thrombosis)	within 30 days post-surgery and at 1 year
Complications: retrograde dissection	Occurrence of retrograde dissection	within 30 days post-surgery and at 1 year
Complications: prolonged ventilation	Occurrence of prolonged ventilation for more than 24 hours	within 30 days post-surgery and at 1 year
Complications: acute kidney injury	Occurrence of acute kidney injury	within 30 days post-surgery and at 1 year
Complications: acute kidney injury with renal replacement therapy	Occurrence of acute kidney injury requiring renal replacement therapy	within 30 days post-surgery and at 1 year
Complications: cardiovascular events	Occurrence of cardiovascular events (myocardial injury after non-cardiac surgery/cardiac arrest/myocardial infarction)	within 30 days post-surgery and at 1 year

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: thoracic endovascular aortic repair; right atrial balloon occlusion; stent graft repair; reduction of elimination of aortic impulse
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Dissection, Thoracic Aorta; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: REB24-1367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No