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Not yet recruiting NCT06786351

Impact of Right Atrial Occlusion on TEVAR Outcomes

— Observational Thoracic Aortic Aneurysm Thoracic Aortic Dissection Thoracic Aorta Abnormality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Right atrial balloon occlusion, Non right atrial balloon occlusion.
Who it may be relevant to
Registry conditions: Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Thoracic Aorta Abnormality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Right atrial balloon occlusion
    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
  • Procedure Non right atrial balloon occlusion
    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 outcome measures

  • Endoleak occurrence up to hospital discharge [Time frame: end of surgery to hospital discharge up to 10 days)]
  • Endoleak occurrence to one-year post-surgery [Time frame: end of surgery to one-year post-surgery]
Secondary outcome measures (11)
  • Perioperative mortality to 30 days post-surgery [Time frame: post-surgery to 30 days post-surgery]
  • All-cause mortality to one-year post-surgery [Time frame: post-surgery to one-year post-surgery]
  • Complications: massive hemorrhage [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: cerebrovascular [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: spinal cord ischemia [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: iliofemoral access [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: retrograde dissection [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: prolonged ventilation [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: acute kidney injury [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: acute kidney injury with renal replacement therapy [Time frame: within 30 days post-surgery and at 1 year]
  • Complications: cardiovascular events [Time frame: within 30 days post-surgery and at 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06786351 · REB24-1367

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗