Aortic Valve StenosisSAVENCT04372381
Supra-Annular vs. Annular ValvEs for Small Annuli
A study testing Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro in people with Aortic Valve Stenosis and Implantation, Heart Valve Prosthesis, run by University of Arizona at 3 sites in United States.
Trial summary
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
- What is being tested?
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 May 2020to 30 Apr 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic subjects with severe native aortic valve stenosis
- aortic valve annulus mean diameter ≤23 mm
- Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- Institutional heart team determines that TAVR is appropriate
- Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Who cannot join
- Subject unable or unwilling to provide informed consent
- Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- Patients at high risk for coronary obstruction
- Patients with low-flow low gradient aortic valve stenosis
- patients at high risk for annular rupture with implantation of a balloon expandable valve
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Delray Medical Center
Delray Beach, Florida, 33484
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, 85006
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Read the detailed description
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
- Being tested
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Keywords
- Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut ProDevice
Treatment of aortic valve stenosis using transcatheter aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Supra-Annular transcatheter heart valve | Active comparator | Medtronic Evolut Pro Valve implantation Receives: Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro |
| Annular transcatheter heart valve | Active comparator | Edwards Sapien 3 Ultra implantation Receives: Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Measured: 1 month
Secondary outcomes (3)
VARC-2 30-day early safety and efficacy
All cause mortality stroke life-threatening bleeding acute kidney injury-stage 2 or 3 coronary artery obstruction major vascular complication valve-related dysfunction requiring repeat procedure NYHA class III or IV Requiring hospitalization for valve-related symptoms or worsening congestive heart failure
Measured: 30 days
Pacemaker implantation
Clinical indication for permanent pacemaker insertion
Measured: 30 days
Prosthetic Valve Dysfunction
Mean aortic valve gradient >= 20 mmHg
>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start12 May 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: No participants enrolled at University of Arizona site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label, Prospective randomized
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East, Henry Ford Health System
- Responsible party
- Sponsor
- Investigators
- Marvin Eng, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372381
- Sponsor's protocol ID
- STUDY00000164
- Acronym
- SAVE
- Status last verified
- Oct 2025
- First submitted
- 27 Apr 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
- ClinicalTrials.gov ID
- NCT04372381
- Acronym / sponsor ID
- SAVE / STUDY00000164
- Keywords
- Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled at University of Arizona site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Corewell Health East, Henry Ford Health System
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 4 May 2020 (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.
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Detailed description
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-Label, Prospective randomized
| Arm | Type | Receives |
|---|---|---|
| Supra-Annular transcatheter heart valve | Active comparator | Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut ProMedtronic Evolut Pro Valve implantation |
| Annular transcatheter heart valve | Active comparator | Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut ProEdwards Sapien 3 Ultra implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic subjects with severe native aortic valve stenosis
- aortic valve annulus mean diameter ≤23 mm
- Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- Institutional heart team determines that TAVR is appropriate
- Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Key exclusion criteria (7 listed)
- Subject unable or unwilling to provide informed consent
- Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- Patients at high risk for coronary obstruction
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 |
|---|---|---|
| Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut ProTreatment of aortic valve stenosis using transcatheter aortic valve replacement | Device | Annular transcatheter heart valve, Supra-Annular transcatheter heart valve |
Primary outcome
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Time frame: 1 month
3 secondary outcomes
VARC-2 30-day early safety and efficacy
Time frame: 30 days
Pacemaker implantation
Time frame: 30 days
Prosthetic Valve Dysfunction
Time frame: 30 days and 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
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.
Marvin Eng, MD principal investigator
University of Arizona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro in people with Aortic Valve Stenosis and Implantation, Heart Valve Prosthesis, run by University of Arizona at 3 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation (time frame: 1 month). 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 24 Jul 2026.