Aortic Valve StenosisNCT01635244
Hemodynamic Comparison of Tissue Aortic Valves
A study testing Aortic valve replacement in people with Aortic Valve Stenosis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves. 2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2.
- Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS.
- Less than moderate aortic regurgitation on preoperative testing.
- Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation.
- Left ventricular ejection fraction ≥ 40% on preoperative testing.
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- Physically able and willing to pedal a recumbent bicycle.
- Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis.
- Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria.
- Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement.
- Willing and able to undergo preoperative echocardiography/Doppler for purposes of the research study.
- Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
Who cannot join
- Age < 18 years.
- AS felt by overall clinical impression to be less than severe.
- Aortic valve replacement is urgent or emergent.
- Moderate of more aortic regurgitation on preoperative testing.
- Concomitant mitral or tricuspid valve replacement.
- Left ventricular ejection fraction < 40% on preoperative testing.
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- Physically unable or unwilling to pedal a recumbent bicycle.
- Planned aortic valve replacement with a mechanical prosthesis.
- Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria.
- Not willing to undergo randomization to have implanted one of three bioprosthesis.
- Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of the research protocol.
- Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
About this study
Official title: Trifecta Comparative Stress Hemodynamic Study (Randomized Comparison of Exercise Hemodynamics and Left Ventricular Remodeling With Aortic Bioprostheses After Aortic Valve Replacement for Aortic Stenosis)
The purpose of this study is to:
- Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves.
- Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.
Read the detailed description
Various aortic valve prostheses have unique hemodynamic characteristics, and there is on-going interest in defining those hemodynamic characteristics in the interest of avoiding residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow obstruction despite a normally functioning prosthesis ) after aortic valve replacement. Attempts to compare hemodynamics between prostheses have been limited by different sizing systems used by various manufacturers (precluding meaningful comparison of valves by valve size) and biological variability of in vivo gradients and effective orifice area for any valve (making potentially small differences in hemodynamics difficult to detect). Assessment of hemodynamics during increased cardiac output associated with exercise testing has been used to better define potentially subtle differences in hemodynamics between valve prostheses. In addition, assessment for change in LV geometry (notably including LV hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic prosthesis hemodynamics.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Aortic valve replacement
- Keywords
- Aortic valve prosthesis, Aortic valve hemodynamics, Prosthesis-patient mismatch, Left ventricular diastolic function, Left ventricular remodeling
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementDevice
Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
| Study group | Role | What they receive |
|---|---|---|
| Freestyle | Active comparator | Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). Receives: Device: Aortic valve replacement |
| Magna Ease | Active comparator | Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). Receives: Device: Aortic valve replacement |
| Trifecta | Active comparator | Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). Receives: Device: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
This is a measure of the resistance to flow across the aortic bioprosthesis.
Measured: 6 months after aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bach, MD, University of Michigan
- Investigators
- David Bach, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635244
- Sponsor's protocol ID
- N015029-00
- Status last verified
- Dec 2016
- First submitted
- 1 Jul 2012
- Last updated
- 3 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bach DS, Patel HJ, Kolias TJ, Deeb GM. Randomized comparison of exercise haemodynamics of Freestyle, Magna Ease and Trifecta bioprostheses after aortic valve replacement for severe aortic stenosis. Eur J Cardiothorac Surg. 2016 Aug;50(2):361-7. doi: 10.1093/ejcts/ezv493. Epub 2016 Jan 27.
PubMed 26819292
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trifecta Comparative Stress Hemodynamic Study (Randomized Comparison of Exercise Hemodynamics and Left Ventricular Remodeling With Aortic Bioprostheses After Aortic Valve Replacement for Aortic Stenosis)
- ClinicalTrials.gov ID
- NCT01635244
- Acronym / sponsor ID
- N015029-00
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve prosthesis, Aortic valve hemodynamics, Prosthesis-patient mismatch, Left ventricular diastolic function, Left ventricular remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Posted 3 Feb 2017
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 study is to:
- Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves.
- Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.
Detailed description
Various aortic valve prostheses have unique hemodynamic characteristics, and there is on-going interest in defining those hemodynamic characteristics in the interest of avoiding residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow obstruction despite a normally functioning prosthesis ) after aortic valve replacement. Attempts to compare hemodynamics between prostheses have been limited by different sizing systems used by various manufacturers (precluding meaningful comparison of valves by valve size) and biological variability of in vivo gradients and effective orifice area for any valve (making potentially small differences in hemodynamics difficult to detect). Assessment of hemodynamics during increased cardiac output associated with exercise testing has been used to better define potentially subtle differences in hemodynamics between valve prostheses. In addition, assessment for change in LV geometry (notably including LV hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic prosthesis hemodynamics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Freestyle | Active comparator | Device: Aortic valve replacementAortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). |
| Magna Ease | Active comparator | Device: Aortic valve replacementAortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). |
| Trifecta | Active comparator | Device: Aortic valve replacementAortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years.
- Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2.
- Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS.
- Less than moderate aortic regurgitation on preoperative testing.
- Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation.
Key exclusion criteria (12 listed)
- Age < 18 years.
- AS felt by overall clinical impression to be less than severe.
- Aortic valve replacement is urgent or emergent.
- Moderate of more aortic regurgitation on preoperative testing.
- Concomitant mitral or tricuspid valve replacement.
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 |
|---|---|---|
| Aortic valve replacementClinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta). | Device | Freestyle, Magna Ease, Trifecta |
Primary outcome
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
Time frame: 6 months after aortic valve replacement
This is a measure of the resistance to flow across the aortic bioprosthesis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26819292Bach DS, Patel HJ, Kolias TJ, Deeb GM. Randomized comparison of exercise haemodynamics of Freestyle, Magna Ease and Trifecta bioprostheses after aortic valve replacement for severe aortic stenosis. Eur J Cardiothorac Surg. 2016 Aug;50(2):361-7. doi: 10.1093/ejcts/ezv493. Epub 2016 Jan 27.
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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.
David Bach, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve replacement in people with Aortic Valve Stenosis, run by University of Michigan 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 12 inclusion and 12 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 3 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise (time frame: 6 months after aortic valve replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635244, which also lists 1 linked publication.
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 3 Feb 2017.