Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)

NCT05146037

Stroke Aortic Valve Stenosis Silent Cerebral Infarct +1 more

UNKNOWN NA

Vascular Complications and Bleeding After Transfemoral TAVI

NCT03865043

Severe and Symptomatic Aortic Stenosis Undergoing TAVI

COMPLETED

Near INfrared Spectroscopy in Aortic valvE ReplacemenT

NCT01251328

Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Eligibility for Both Anaesthetic Methods

COMPLETED NA

Pilot Study of Cognitive and Functional Outcomes Following TAVI

NCT02089945

Aortic Stenosis

COMPLETED

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

NCT05082337

Aortic Valve Disease Transcatheter Aortic Valve Replacement Aortic Valve Stenosis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Aortic Aneurysm Aortic Stenosis Symptomatic Stroke, Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline Flush

This is the control arm. The TEVAR or TAVI device will be flushed with at least 60mL of standard saline to reduce bubbles in the reservoir prior to deployment. This is the standard of care.

Group Type PLACEBO_COMPARATOR

Standard Saline Flush

Intervention Type PROCEDURE

Standard of care flushing of the TEVAR or TAVI device with normal saline.

Carbon Dioxide and Saline Flush

Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.

Group Type EXPERIMENTAL

Carbon Dioxide and Saline Flush

Intervention Type PROCEDURE

The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carbon Dioxide and Saline Flush

The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.

Intervention Type PROCEDURE

Standard Saline Flush

Standard of care flushing of the TEVAR or TAVI device with normal saline.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cook Zenith alpha thoracic endovascular graft Sapien Transcatheter Heart Valve CoreValve Trascatheter Aortic Valve Cook Zenith alpha thoracic endovascular graft Sapien Transcatheter heart valve Core Valve Transcatheter Aortic Valve

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Elective TEVAR or TAVI
* Over 18 years old

Exclusion Criteria

* Recent acute myocardial infarction
* Recent stroke or TIA
* Post or pending organ transplantation
* Active peptic ulcer disease
* Recent gastrointestinal bleed
* History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy.
* Permanent pacemaker or ICD
* History of atrial fibrillation
* Moderate or severe allergy to iodinated contrast not amenable to predmedication
* Renal failure
* Unable to safely undergo MRI
* Enrollment in another study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No