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NCT Number: NCT06786351

Impact of Right Atrial Occlusion on TEVAR Outcomes

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.

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Key information

Conditions

Thoracic Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Dissection, Thoracic Aorta Thoracic Aorta Abnormality Thoracic Aortic Dissection Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Endoleak occurrence up to hospital discharge

    Time frame: end of surgery to hospital discharge up to 10 days)

    Endoleak occurrence prior to hospital discharge

  2. Endoleak occurrence to one-year post-surgery

    Time frame: end of surgery to one-year post-surgery

    Endoleak occurrence within one-year of surgery

Secondary outcomes

  1. Perioperative mortality to 30 days post-surgery

    Time frame: post-surgery to 30 days post-surgery

    30-day perioperative mortality

  2. All-cause mortality to one-year post-surgery

    Time frame: post-surgery to one-year post-surgery

    One-year all-cause mortality

  3. Complications: massive hemorrhage

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of massive hemorrhage

  4. Complications: cerebrovascular

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of cerebrovascular accident/transient ischemic attack

  5. Complications: spinal cord ischemia

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of spinal cord ischemia

  6. Complications: iliofemoral access

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of iliofemoral access complications (bleeding/infection/thrombosis)

  7. Complications: retrograde dissection

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of retrograde dissection

  8. Complications: prolonged ventilation

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of prolonged ventilation for more than 24 hours

  9. Complications: acute kidney injury

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of acute kidney injury

  10. Complications: acute kidney injury with renal replacement therapy

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of acute kidney injury requiring renal replacement therapy

  11. Complications: cardiovascular events

    Time frame: within 30 days post-surgery and at 1 year

    Occurrence of cardiovascular events (myocardial injury after non-cardiac surgery/cardiac arrest/myocardial infarction)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Allen, MD, FRCPC

CONTACT

[email protected]

403-

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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