Aortic Valve StenosisCREATENCT07734025
A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
A study testing Investigational Transcatheter Aortic Valve Replacement System in people with Aortic Valve Stenosis and Severe Aortic Stenosis, run by Onecrea Medical Inc..
Trial summary
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis, Severe Aortic Stenosis
- What is being tested?
- Investigational Transcatheter Aortic Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2026to 30 Jun 2033
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older.
- Symptomatic severe native calcific aortic valve stenosis.
- Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
- Considered at high surgical risk for surgical aortic valve replacement.
- Able to understand the study requirements and provide written informed consent.
- Willing and able to comply with all study procedures and follow-up visits.
Who cannot join
- Contraindication to transcatheter aortic valve replacement or the investigational procedure.
- Active infection or endocarditis.
- Life expectancy less than one year due to non-cardiac comorbidities.
- Participation in another investigational study that could interfere with the objectives of this study.
- Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.
About this study
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.
The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.
Read the detailed description
Severe symptomatic aortic valve stenosis is a progressive disease associated with significant morbidity and mortality if left untreated. Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for appropriately selected patients with severe native aortic valve disease who are considered suitable candidates for transcatheter intervention.
This clinical investigation is designed to evaluate an investigational transcatheter aortic valve replacement system developed for the treatment of severe symptomatic native aortic valve stenosis. The study will collect clinical evidence to assess the safety and performance of the investigational device in accordance with the Clinical Investigation Plan and applicable regulatory requirements.
- Conditions
- Aortic Valve Stenosis, Severe Aortic Stenosis
- Being tested
- Investigational Transcatheter Aortic Valve Replacement System
- Keywords
- Transcatheter Aortic Valve Replacement, TAVR, Transcatheter Aortic Valve Implantation, Aortic Valve Stenosis
- 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.
Investigational Transcatheter Aortic Valve Replacement SystemDevice
Investigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Investigational TAVR Device | Experimental | Participants will receive the investigational transcatheter aortic valve replacement (TAVR) system for the treatment of severe symptomatic native aortic valve stenosis according to the Clinical Investigation Plan. Receives: Device: Investigational Transcatheter Aortic Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Technical Success
Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria.
Measured: At completion of the index procedure (exit from procedure room)
Percentage of Participants With Device Success
Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria.
Measured: 30 days after the procedure
Percentage of Participants Free From Early Safety Events
Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan.
Measured: 30 days after the procedure
Secondary outcomes (9)
All-cause Mortality rate
Assessment of all-cause mortality following implantation of the investigational transcatheter aortic valve replacement system
Measured: Through 5 years
Cardiovascular Mortality Rate
Assessment of cardiovascular mortality during follow-up.
Measured: Through 5 years
Percentage of Participants Experiencing Stroke
Assessment of stroke events occurring during the follow-up period
Measured: Through 5 years
Rate of Valve- or Procedure-Related Rehospitalization
Assessment of valve- or procedure-related rehospitalization during follow-up
Measured: Through 5 years
Hemodynamic Valve Performance assessed by Echocardiography
Assessment of prosthetic valve performance using echocardiographic evaluations
Measured: Through 5 years
Change From Baseline in NYHA Functional Class
Change in New York Heart Association (NYHA) functional class following treatment.
Measured: Baseline through 5 years
Change From Baseline in Six-Minute Walk Test (6MWT) Distance
Change in six-minute walk test (6MWT) distance during follow-up.
Measured: Baseline through 5 years
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score during follow-up
Measured: Baseline through 5 years
Percentage of Permanent Pacemaker Implantation
Assessment of new permanent pacemaker implantation following the procedure
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start4 Dec 2026 (estimated)
- Primary completion7 Dec 2027 (estimated)
- Study completion30 Jun 2033 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the investigational transcatheter aortic valve replacement system. This is a prospective, multicenter, single-arm pivotal clinical investigation designed to evaluate the safety and performance of the investigational device.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onecrea Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734025
- Sponsor's protocol ID
- CT-XXXX-CAVS-2025
- Acronym
- CREATE
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. Data will be maintained by the sponsor and may be disclosed only as required by applicable laws, regulations, or agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
- ClinicalTrials.gov ID
- NCT07734025
- Acronym / sponsor ID
- CREATE / CT-XXXX-CAVS-2025
- Conditions
- Aortic Valve Stenosis, Severe Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, TAVR, Transcatheter Aortic Valve Implantation, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Onecrea Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2026 (estimated)
- Primary completion
- 7 Dec 2027 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 29 Jul 2026 (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.
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.
The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.
Detailed description
Severe symptomatic aortic valve stenosis is a progressive disease associated with significant morbidity and mortality if left untreated. Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for appropriately selected patients with severe native aortic valve disease who are considered suitable candidates for transcatheter intervention.
This clinical investigation is designed to evaluate an investigational transcatheter aortic valve replacement system developed for the treatment of severe symptomatic native aortic valve stenosis. The study will collect clinical evidence to assess the safety and performance of the investigational device in accordance with the Clinical Investigation Plan and applicable regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the investigational transcatheter aortic valve replacement system. This is a prospective, multicenter, single-arm pivotal clinical investigation designed to evaluate the safety and performance of the investigational device.
| Arm | Type | Receives |
|---|---|---|
| Investigational TAVR Device | Experimental | Device: Investigational Transcatheter Aortic Valve Replacement SystemParticipants will receive the investigational transcatheter aortic valve replacement (TAVR) system for the treatment of severe symptomatic native aortic valve stenosis according to the Clinical Investigation Plan. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 years or older.
- Symptomatic severe native calcific aortic valve stenosis.
- Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
- Considered at high surgical risk for surgical aortic valve replacement.
- Able to understand the study requirements and provide written informed consent.
Key exclusion criteria (5 listed)
- Contraindication to transcatheter aortic valve replacement or the investigational procedure.
- Active infection or endocarditis.
- Life expectancy less than one year due to non-cardiac comorbidities.
- Participation in another investigational study that could interfere with the objectives of this study.
- Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.
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 |
|---|---|---|
| Investigational Transcatheter Aortic Valve Replacement SystemInvestigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis. | Device | Investigational TAVR Device |
Primary outcome
Percentage of Participants With Technical Success
Time frame: At completion of the index procedure (exit from procedure room)
Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria.
Percentage of Participants With Device Success
Time frame: 30 days after the procedure
Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria.
Percentage of Participants Free From Early Safety Events
Time frame: 30 days after the procedure
Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan.
9 secondary outcomes
All-cause Mortality rate
Time frame: Through 5 years
Cardiovascular Mortality Rate
Time frame: Through 5 years
Percentage of Participants Experiencing Stroke
Time frame: Through 5 years
Rate of Valve- or Procedure-Related Rehospitalization
Time frame: Through 5 years
Hemodynamic Valve Performance assessed by Echocardiography
Time frame: Through 5 years
Change From Baseline in NYHA Functional Class
Time frame: Baseline through 5 years
Change From Baseline in Six-Minute Walk Test (6MWT) Distance
Time frame: Baseline through 5 years
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score
Time frame: Baseline through 5 years
Percentage of Permanent Pacemaker Implantation
Time frame: Through 5 years
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 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. Data will be maintained by the sponsor and may be disclosed only as required by applicable laws, regulations, or agreements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Transcatheter Aortic Valve Replacement System in people with Aortic Valve Stenosis and Severe Aortic Stenosis, run by Onecrea Medical 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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?
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?
Percentage of Participants With Technical Success (time frame: At completion of the index procedure (exit from procedure room)). The study lists 3 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 29 Jul 2026.