Impact of Right Atrial Occlusion on TEVAR Outcomes

NCT ID: NCT06786351

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Aortic Aneurysm Thoracic Aortic Dissection Thoracic Aorta Abnormality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Right atrial balloon occlusion

Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse

Right atrial balloon occlusion

Intervention Type 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

Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse

Non right atrial balloon occlusion

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Claire Allen

Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Claire Allen, MD, FRCPC

Role: CONTACT

Other Identifiers

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REB24-1367

Identifier Type: -

Identifier Source: org_study_id

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