Valve Heart DiseaseNCT03347851
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
An observational study of Valve Heart Disease, run by CryoLife, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Valve Heart Disease
- What is being tested?
- MRI and Transthoracic echocardiography exam
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
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.
Read the detailed description
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
- Valve Heart Disease
- Being tested
- MRI, Transthoracic echocardiography exam
- Keywords
- mechanical heart valve, On-X
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Enrolled patients will complete a non-contrast cardiac MRI
Transthoracic echocardiography examOther
Enrolled patients will complete a transthoracic echocardiography exam.
| Study group | Role | What they receive |
|---|---|---|
| On-X AAP | Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP). Receives: Other: MRI; Other: 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 Receives: Other: MRI; Other: Transthoracic echocardiography exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Downstream flow patterns (helicity and vorticity)
MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Measured: 3 months
Hinge washout
MRI data analysis; Yes/No
Measured: 3 months
Energy loss
MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss.
Measured: 3 months
Wall shear stress (WSS)
MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
Measured: 3 months
Secondary outcomes (11)
Ejection Fraction (%)
Measured: 3 months
Primary EDV (ml)
End Diastolic Volume
Measured: 3 months
Normalized EDV (ml/m^2)
End Diastolic Volume
Measured: 3 months
Primary ESV (mL)
End Systolic Volume
Measured: 3 months
Normalized ESV (mL/m^2)
End Systolic Volume
Measured: 3 months
Peak Velocity (m/s)
Measured: 3 months
Mean velocity (m/s)
Measured: 3 months
Peak transvalvular pressure gradient (mmHg)
Measured: 3 months
Mean transvalvular pressure gradient (mmHg)
Measured: 3 months
Effective Orifice Area (EOA)
Measured: 3 months
Effective Orifice Area index (EOAi)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start26 Oct 2017
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347851
- Sponsor's protocol ID
- 2017-1
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03347851
- Acronym / sponsor ID
- 2017-1
- Conditions
- Valve Heart Disease
- Keywords
- mechanical heart valve, On-X
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CryoLife, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-X AAP | – | Other: MRI, Other: Transthoracic echocardiography examPatients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP). |
| SJM Masters or Carbomedics Carbo-seal | – | Other: MRI, Other: Transthoracic echocardiography examPatients 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIEnrolled patients will complete a non-contrast cardiac MRI | Other | On-X AAP, SJM Masters or Carbomedics Carbo-seal |
| Transthoracic echocardiography examEnrolled patients will complete a transthoracic echocardiography exam. | Other | On-X AAP, SJM Masters or Carbomedics Carbo-seal |
Primary outcome
Downstream flow patterns (helicity and vorticity)
Time frame: 3 months
MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Hinge washout
Time frame: 3 months
MRI data analysis; Yes/No
Energy loss
Time frame: 3 months
MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss.
Wall shear stress (WSS)
Time frame: 3 months
MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
11 secondary outcomes
Ejection Fraction (%)
Time frame: 3 months
Primary EDV (ml)
Time frame: 3 months
Normalized EDV (ml/m^2)
Time frame: 3 months
Primary ESV (mL)
Time frame: 3 months
Normalized ESV (mL/m^2)
Time frame: 3 months
Peak Velocity (m/s)
Time frame: 3 months
Mean velocity (m/s)
Time frame: 3 months
Peak transvalvular pressure gradient (mmHg)
Time frame: 3 months
Mean transvalvular pressure gradient (mmHg)
Time frame: 3 months
Effective Orifice Area (EOA)
Time frame: 3 months
Effective Orifice Area index (EOAi)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Heart Disease, run by CryoLife, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Downstream flow patterns (helicity and vorticity) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.