Impact of Right Atrial Occlusion on TEVAR Outcomes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Right atrial balloon occlusion
Procedure/SurgeryThoracic 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
Procedure/SurgeryThoracic 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Right atrial balloon occlusion1 intervention
Group B: Non right atrial balloon occlusion1 intervention
Trial outcomes
Primary outcomes
1
Endoleak occurrence up to hospital discharge
Endoleak occurrence prior to hospital discharge
Time frame
end of surgery to hospital discharge up to 10 days)2
Endoleak occurrence to one-year post-surgery
Endoleak occurrence within one-year of surgery
Time frame
end of surgery to one-year post-surgerySecondary outcomes
1
Perioperative mortality to 30 days post-surgery
30-day perioperative mortality
Time frame
post-surgery to 30 days post-surgery2
All-cause mortality to one-year post-surgery
One-year all-cause mortality
Time frame
post-surgery to one-year post-surgery3
Complications: massive hemorrhage
Occurrence of massive hemorrhage
Time frame
within 30 days post-surgery and at 1 year4
Complications: cerebrovascular
Occurrence of cerebrovascular accident/transient ischemic attack
Time frame
within 30 days post-surgery and at 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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