Aortic Valve DiseaseNCT06506903
Avalus Ultra Post-Approval Study (PAS)
A study testing Medtronic Avalus Ultra in people with Aortic Valve Disease, run by Medtronic Cardiac Surgery at 15 sites in United States.
Trial summary
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Medtronic Avalus Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 15 sitesUnited States
- Study dates
- 20 Nov 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects must meet the following criteria to be included in the study:
- Subject has moderate or greater aortic stenosis or regurgitation, and there is a clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
- Atrial fibrillation (AF) ablation
- Ascending aortic aneurysm or dissection repair or replacement, with or without circulatory arrest
- Coronary artery bypass graft (CABG)
- Surgical management of the left atrial appendage (LAA)
Show all 11Show fewer
- Patent foramen ovale (PFO) closure
- Resection of a sub-aortic membrane not requiring myectomy
- Subject is geographically stable and willing to return to the implanting site for all follow-up visits
- Subject is of legal age to provide informed consent
- Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the study
Who cannot join
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Subject has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary, or tricuspid valve
- Subject has had a previous implant and then explant of the Avalus Ultra aortic valve bioprosthesis within the Avalus Ultra Post-Approval Study
- Subject presents with active endocarditis, active myocarditis, or other systemic infection
- Subject has a known hypersensitivity to contrast media that cannot be adequately premedicated
- Subject has a known hypersensitivity to platinum, iridium, or tantalum
Show all 28Show fewer
- Subject has an anatomical abnormality that would increase surgical risk of morbidity or mortality, including:
- Acute Type A aortic dissection
- Ventricular aneurysm
- Porcelain aorta
- Hostile mediastinum
- Hypertrophic obstructive cardiomyopathy
- Documented pulmonary hypertension (systolic >60mmHg)
- Subject has a non-cardiac major or progressive disease with a life expectancy of less than 1 year. These conditions include but are not limited to:
- Child-Pugh Class C liver disease
- Terminal cancer
- End-stage lung disease
- Subject has renal failure, defined by dialysis therapy or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
- Subject has active or untreated hyperparathyroidism
- Subject is participating in another investigational device or drug trial (not including registries)
- Subject is pregnant, lactating, or planning to become pregnant during the study period
- Subject has a documented history of substance (drug or alcohol) abuse
- Subject has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
- Subject has systolic ejection fraction (EF) <20% as assessed by echocardiography
- Subject has Grade IV diastolic dysfunction
- Subject has documented bleeding diatheses
- Subject has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to implant
- Subject requires emergency surgery
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109
Emory Saint Joseph's
Atlanta, Georgia, 30342
Heart Hospital of Austin
Austin, Texas, 78756
Northwestern Memorial Hospital
Chicago, Illinois, 60611
UH Cleveland Medical Center
Cleveland, Ohio, 44106
University of Florida Shands
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06106
CHI Saint Lukes Health - Baylor Saint Lukes Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
WellStar Kennestone Hospital
Marietta, Georgia, 30060
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55902
Swedish Medical Center Cherry Hill
Seattle, Washington, 98122
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
ProMedica Toledo Hospital
Toledo, Ohio, 43606
About this study
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
Read the detailed description
A prospective, multi-center, single-arm, interventional, non-randomized, post-market study to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease. Approximately 150 subjects in the United States will be implanted and followed through one year post-procedure.
- Conditions
- Aortic Valve Disease
- Being tested
- Medtronic Avalus Ultra
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Avalus UltraDevice
Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| Avalus Ultra | Experimental | Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm Receives: Device: Medtronic Avalus Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-related incidence of adverse events and death through 1 year post-procedure
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: thromboembolism, valve thrombosis, hemorrhage, paravalvular leak, endocarditis, structural valve deterioration, non-structural valve dysfunction, reintervention, death. This safety endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of safety endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited the study.
Measured: 30 days and 1 year post-procedure
Evaluation of Mean Pressure Gradient (mmHg) through 1 year post-procedure
Mean pressure gradient is evaluated by transthoracic echocardiography technique as the average flow of blood through the aortic valve measured in millimeters of mercury. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Measured: 30 days and 1 year post-procedure
Evaluation of Effective Orifice Area (cm^2) through 1 year post-procedure
Effective Orifice Area (EOA) is assessed by transthoracic echocardiography technique and is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Measured: 30 days and 1 year post-procedure
Change in heart failure status based on NYHA functional classification from baseline through 1 year post-procedure
The change of the New York Heart Association (NYHA) functional classification at 30 days and 1 year from baseline will be used to evaluate the change heart failure status. The primary analysis will occur once all implanted participants have completed their 1 year visit or exited; no statistical hypothesis testing will be performed.
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: 30 days and 1 year post-procedure
Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT)
This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Measured: 1 year post-procedure
Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT)
This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start20 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Crestanello, MD, Principal investigator, Mayo ClinicBo Yang, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506903
- Sponsor's protocol ID
- MDT23007
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avalus Ultra Post-Approval Study (PAS)
- ClinicalTrials.gov ID
- NCT06506903
- Acronym / sponsor ID
- MDT23007
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Jul 2024 (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 study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
Detailed description
A prospective, multi-center, single-arm, interventional, non-randomized, post-market study to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease. Approximately 150 subjects in the United States will be implanted and followed through one year post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avalus Ultra | Experimental | Device: Medtronic Avalus UltraAvalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has moderate or greater aortic stenosis or regurgitation, and there is a clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
- Subject is geographically stable and willing to return to the implanting site for all follow-up visits
- Subject is of legal age to provide informed consent
- Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the study
Key exclusion criteria (28 listed)
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Subject has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary, or tricuspid valve
- Subject has had a previous implant and then explant of the Avalus Ultra aortic valve bioprosthesis within the Avalus Ultra Post-Approval Study
- Subject presents with active endocarditis, active myocarditis, or other systemic infection
- Subject has a known hypersensitivity to contrast media that cannot be adequately premedicated
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 |
|---|---|---|
| Medtronic Avalus UltraSurgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation. | Device | Avalus Ultra |
Primary outcome
Time-related incidence of adverse events and death through 1 year post-procedure
Time frame: 30 days and 1 year post-procedure
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: thromboembolism, valve thrombosis, hemorrhage, paravalvular leak, endocarditis, structural valve deterioration, non-structural valve dysfunction, reintervention, death. This safety endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of safety endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited the study.
Evaluation of Mean Pressure Gradient (mmHg) through 1 year post-procedure
Time frame: 30 days and 1 year post-procedure
Mean pressure gradient is evaluated by transthoracic echocardiography technique as the average flow of blood through the aortic valve measured in millimeters of mercury. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Evaluation of Effective Orifice Area (cm^2) through 1 year post-procedure
Time frame: 30 days and 1 year post-procedure
Effective Orifice Area (EOA) is assessed by transthoracic echocardiography technique and is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Change in heart failure status based on NYHA functional classification from baseline through 1 year post-procedure
Time frame: 30 days and 1 year post-procedure
The change of the New York Heart Association (NYHA) functional classification at 30 days and 1 year from baseline will be used to evaluate the change heart failure status. The primary analysis will occur once all implanted participants have completed their 1 year visit or exited; no statistical hypothesis testing will be performed. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT)
Time frame: 1 year post-procedure
This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT)
Time frame: 1 year post-procedure
This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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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.
Juan Crestanello, MD principal investigator
Mayo Clinic
Bo Yang, MD, PhD principal investigator
University of Michigan
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Avalus Ultra in people with Aortic Valve Disease, run by Medtronic Cardiac Surgery at 15 sites 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 11 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Time-related incidence of adverse events and death through 1 year post-procedure (time frame: 30 days and 1 year post-procedure). The study lists 6 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 21 Apr 2026.