Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

NCT ID: NCT03347851

Last Updated: 2021-03-04

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-26

Study Completion Date

2020-06-01

Brief Summary

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

The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.

Detailed Description

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

Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.

Conditions

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

Valve Heart Disease

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

On-X AAP

Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).

MRI

Intervention Type OTHER

Enrolled patients will complete a non-contrast cardiac MRI

Transthoracic echocardiography exam

Intervention Type OTHER

Enrolled patients will complete a transthoracic echocardiography exam.

SJM Masters or Carbomedics Carbo-seal

Patients with St. Jude Medical Masters HP Valved Graft with Gelweave Valsalva™ Technology or Carbomedics Carbo-seal (including Carbo-seal Valsalva) mechanical aortic valve prostheses patients

MRI

Intervention Type OTHER

Enrolled patients will complete a non-contrast cardiac MRI

Transthoracic echocardiography exam

Intervention Type OTHER

Enrolled patients will complete a transthoracic echocardiography exam.

Interventions

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

MRI

Enrolled patients will complete a non-contrast cardiac MRI

Intervention Type OTHER

Transthoracic echocardiography exam

Enrolled patients will complete a transthoracic echocardiography exam.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Male and female subjects 18-89 years of age
* Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.

Exclusion Criteria

* Patients contraindicated against MRI
* Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal
* Patients unwilling or unable to give written informed consent
* Pregnant women
* Prisoners
* Patients with an Effective Orifice Area index (EOAi) \<0.85 cm2/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role collaborator

CryoLife, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Valvular Heart Disease Registry
NCT03488732 RECRUITING
J-Valve Transfemoral Pivotal Study
NCT06455787 RECRUITING NA
Omics in Valvular Disease
NCT05768594 UNKNOWN