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Not yet recruitingNCT06786351Updated Jun 29, 2025

Impact of Right Atrial Occlusion on TEVAR Outcomes

An observational study in Thoracic Aortic Aneurysm, Thoracic Aortic Dissection and Thoracic Aorta Abnormality, sponsored by University of Calgary. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by University of Calgary · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 100 is below the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureRight 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

  • ProcedureNon 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

06

What researchers measure

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-surgery

Secondary outcomes

  1. Perioperative mortality to 30 days post-surgery

    30-day perioperative mortality

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

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

    One-year all-cause mortality

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

  3. Complications: massive hemorrhage

    Occurrence of massive hemorrhage

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

  4. Complications: cerebrovascular

    Occurrence of cerebrovascular accident/transient ischemic attack

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

  5. Complications: spinal cord ischemia

    Occurrence of spinal cord ischemia

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

  6. Complications: iliofemoral access

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

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

  7. Complications: retrograde dissection

    Occurrence of retrograde dissection

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

  8. Complications: prolonged ventilation

    Occurrence of prolonged ventilation for more than 24 hours

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

  9. Complications: acute kidney injury

    Occurrence of acute kidney injury

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

  10. Complications: acute kidney injury with renal replacement therapy

    Occurrence of acute kidney injury requiring renal replacement therapy

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

  11. Complications: cardiovascular events

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

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2025; primary completion for Jan 2029, 40 months later.

Of 42 observational studies under Aortic Aneurysm, Thoracic, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 98. This study's planned 40 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2025
First posted
Jan 22, 2025
StartEst.
Sep 1, 2025
Primary completionEst.
Jan 31, 2029
CompletionEst.
Jan 31, 2029
Last update
Jun 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06786351
Responsible party
Claire Allen (Clinical Lecturer, University of Calgary) — Principal investigator
First posted
Jan 22, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Jun 29, 2025

Study contacts

Claire Allen, MD, FRCPC
Contact
claire.allen@ahs.ca
403-

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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