Impact of Right Atrial Occlusion on TEVAR Outcomes

NCT06786351 | Not Yet Recruiting

• 1 other identifier: REB24-1367
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Perioperative mortality to 30 days post-surgery

  post-surgery to 30 days post-surgery

• All-cause mortality to one-year post-surgery

  post-surgery to one-year post-surgery

• Complications: massive hemorrhage

  within 30 days post-surgery and at 1 year

• Complications: cerebrovascular

  within 30 days post-surgery and at 1 year

• Complications: spinal cord ischemia

  within 30 days post-surgery and at 1 year

Study Arms (2)

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

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

Interventions

Right atrial balloon occlusion PROCEDURE

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

Right atrial balloon occlusion

Non right atrial balloon occlusion PROCEDURE

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

Non right atrial balloon occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Claire Allen, MD, FRCPC

CONTACT

403-; claire.allen@ahs.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06