Clinical trial NCT06786351: Impact of Right Atrial Occlusion on TEVAR Outcomes
Official title: Impact of Right Atrial Occlusion on TEVAR Outcomes: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Thoracic Aorta Abnormality
Keywords: right atrial balloon occlusion
thoracic endovascular aortic repair
stent graft repair
reduction of elimination of aortic impulse
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endoleak occurrence up to hospital discharge
timeFrame: end of surgery to hospital discharge up to 10 days)
measure: Endoleak occurrence to one-year post-surgery
timeFrame: end of surgery to one-year post-surgery
Secondary outcomes:
measure: Perioperative mortality to 30 days post-surgery
timeFrame: post-surgery to 30 days post-surgery
measure: All-cause mortality to one-year post-surgery
timeFrame: post-surgery to one-year post-surgery
measure: Complications: massive hemorrhage
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: cerebrovascular
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: spinal cord ischemia
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: iliofemoral access
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: retrograde dissection
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: prolonged ventilation
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: acute kidney injury
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: acute kidney injury with renal replacement therapy
timeFrame: within 30 days post-surgery and at 1 year
measure: Complications: cardiovascular events
timeFrame: within 30 days post-surgery and at 1 year
Other outcomes:
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