Impact of Right Atrial Occlusion on TEVAR Outcomes

Not yet recruiting

• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Thoracic Aorta Abnormality

• Registration Number: NCT06786351
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-22
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Start: 2025-05-30
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoleak occurrence up to hospital discharge	end of surgery to hospital discharge up to 10 days)	Endoleak occurrence prior to hospital discharge
Endoleak occurrence to one-year post-surgery	end of surgery to one-year post-surgery	Endoleak occurrence within one-year of surgery

Secondary Outcome Measures

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