Impact of Right Atrial Occlusion on TEVAR Outcomes

June 25, 2025 updated by: Claire Allen, University of Calgary

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endoleak occurrence up to hospital discharge
Time Frame: end of surgery to hospital discharge up to 10 days)
Endoleak occurrence prior to hospital discharge
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
Endoleak occurrence within one-year of surgery
end of surgery to one-year post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative mortality to 30 days post-surgery
Time Frame: post-surgery to 30 days post-surgery
30-day perioperative mortality
post-surgery to 30 days post-surgery
All-cause mortality to one-year post-surgery
Time Frame: post-surgery to one-year post-surgery
One-year all-cause mortality
post-surgery to one-year post-surgery
Complications: massive hemorrhage
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of massive hemorrhage
within 30 days post-surgery and at 1 year
Complications: cerebrovascular
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of cerebrovascular accident/transient ischemic attack
within 30 days post-surgery and at 1 year
Complications: spinal cord ischemia
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of spinal cord ischemia
within 30 days post-surgery and at 1 year
Complications: iliofemoral access
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of iliofemoral access complications (bleeding/infection/thrombosis)
within 30 days post-surgery and at 1 year
Complications: retrograde dissection
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of retrograde dissection
within 30 days post-surgery and at 1 year
Complications: prolonged ventilation
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of prolonged ventilation for more than 24 hours
within 30 days post-surgery and at 1 year
Complications: acute kidney injury
Time Frame: within 30 days post-surgery and at 1 year
Occurrence of acute kidney injury
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
Occurrence of acute kidney injury requiring renal replacement therapy
within 30 days post-surgery and at 1 year
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)
within 30 days post-surgery and at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB24-1367

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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