Moderate Aortic Valve StenosisNCT07060183
Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study
A study testing Ross procedure in people with Moderate Aortic Valve Stenosis, run by Dermed Diagnostics, Inc..
Trial summary
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Moderate Aortic Valve Stenosis
- What is being tested?
- Ross procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Feb 2029
- 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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate aortic stenosis, defined by transthoracic echocardiograph
- Max aortic velocity less than 4.0 m/sec.
- Mean aortic gradient less than 40.0 mmHg.
- 1.0 cm2 < Aortic Valve Area < 1.5 cm2.
- Left ventricular decompensation
Who cannot join
- Not suitable for the Ross procedure.
- Documented history of cardiac amyloidosis.
About this study
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.
Read the detailed description
Single-center prospective study. Subjects with moderate aortic stenosis and left ventricular decompensation will receive aortic valve replacement by the Ross procedure.
- Conditions
- Moderate Aortic Valve Stenosis
- Being tested
- Ross procedure
- Keywords
- aortic, stenosis, valve, decompensation, moderate
- Medical subject headings
- Constriction, Pathologic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ross procedureProcedure or surgery
aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Aortic Valve Replacement Receives: Procedure: Ross procedure |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rates of all-cause mortality or morbidity
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to procedure-related complication, or valve dysfunction requiring reintervention.
Measured: 12 months
Secondary outcomes (1)
Left ventricular compensation
Improvement in left ventricular function from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermed Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur P DeMarzo, Study director, Dermed Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060183
- Sponsor's protocol ID
- Moderate Aortic Stenosis AVR
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study
- ClinicalTrials.gov ID
- NCT07060183
- Acronym / sponsor ID
- Moderate Aortic Stenosis AVR
- Conditions
- Moderate Aortic Valve Stenosis
- Keywords
- aortic, stenosis, valve, decompensation, moderate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dermed Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 Jul 2025 (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.
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.
Detailed description
Single-center prospective study. Subjects with moderate aortic stenosis and left ventricular decompensation will receive aortic valve replacement by the Ross procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Ross procedureAortic Valve Replacement |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate aortic stenosis, defined by transthoracic echocardiograph
- Max aortic velocity less than 4.0 m/sec.
- Mean aortic gradient less than 40.0 mmHg.
- 1.0 cm2 < Aortic Valve Area < 1.5 cm2.
- Left ventricular decompensation
Key exclusion criteria (2 listed)
- Not suitable for the Ross procedure.
- Documented history of cardiac amyloidosis.
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 |
|---|---|---|
| Ross procedureaortic valve replacement | Procedure or surgery | Intervention |
Primary outcome
Composite rates of all-cause mortality or morbidity
Time frame: 12 months
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to procedure-related complication, or valve dysfunction requiring reintervention.
1 secondary outcome
Left ventricular compensation
Time frame: 12 months
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 11 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Arthur P DeMarzo study director
Dermed Diagnostics, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Ross procedure in people with Moderate Aortic Valve Stenosis, run by Dermed Diagnostics, Inc..
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 2 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 rates of all-cause mortality or morbidity (time frame: 12 months). 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 11 Jul 2025.