Severe Aortic StenosisPARADIGMNCT07194265
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
A study testing TAVR with DurAVR® THV and TAVR with SAPIEN THV series or the Evolut THV series in people with Severe Aortic Stenosis and Valve-in-valve Procedures, run by Anteris Technologies Ltd. at 1 site in Denmark.
Trial summary
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Valve-in-valve Procedures
- What is being tested?
- TAVR with DurAVR® THV and TAVR with SAPIEN THV series or the Evolut THV series
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Oct 2025to Mar 2038
- 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
- Native Aortic Stenosis Cohorts:
- The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
- The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
- Subject understands the study requirements and the treatment procedure and provides written informed consent.
- ViV Registry Cohort:
- Severe degeneration of a surgically implanted aortic bioprosthetic valve.
- Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
- Subject understands the study requirements and the treatment procedure and provides written informed consent.
Who cannot join
- Native Aortic Stenosis Cohorts:
- Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
- Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
- Evidence of an acute myocardial infarction 30 days before randomization.
- AV is unicuspid, Type 0 bicuspid, or is non-calcified.
- Severe total aortic regurgitation
Show all 27Show fewer
- Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
- Pre-existing mechanical or bioprosthetic valve in any position.
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- Active bacterial endocarditis in the last 3 months.
- Estimated life expectancy (after TAVR) <12 months.
- Subject is not a candidate for both arms (investigational and control) of the study.
- Subject belongs to a vulnerable population
- ViV Registry Cohort:
- Anatomy precluding safe placement of DurAVR THV.
- Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
- Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
- Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- Need for emergency surgery for any reason
- GI bleeding within the past 3 months.
- Active bacterial endocarditis in the last 3 months.
- Estimated life expectancy (after TAVR) <12 months.
- Subject belongs to a vulnerable population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Capital Region of Denmark, 2100
Ole De Backer, MD, PhD, MBA, +45 3545 7086, ole.debacker@gmail.com
About this study
Official title: A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices
Prospective, randomized, controlled, multicenter, international study.
Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.
Read more
After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.
Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
- Conditions
- Severe Aortic Stenosis, Valve-in-valve Procedures
- Being tested
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Keywords
- tavr, severe calcific aortic stenosis, failed surgical bioprosthesis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR with DurAVR® THVDevice
Transcatheter aortic valve replacement (TAVR)
TAVR with SAPIEN THV series or the Evolut THV seriesDevice
Transcatheter aortic valve replacement (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| DurAVR THV | Experimental | DurAVR® THV implantation Receives: Device: TAVR with DurAVR® THV |
| Control | Active comparator | SAPIEN THV series or the Evolut THV series implantation Receives: Device: TAVR with SAPIEN THV series or the Evolut THV series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Measured: 1 Year
Secondary outcomes (5)
All-cause mortality
Mortality from any cause will by collected by tracking patient's living status via medical record
Measured: 30 Days
Disabling stroke according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 30 Days
Life-threatening bleeding according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 30 Days
Major vascular complication according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 30 Days
Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start21 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic 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
- Subjects will be randomized 1:1 to receive either TAVR using the DurAVR® THV System or TAVR using any commercially available and approved THV from the SAPIEN series or the Evolut series in the "All Comers Randomized Cohort"
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anteris Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194265
- Sponsor's protocol ID
- SP0083
- Acronym
- PARADIGM
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices
- ClinicalTrials.gov ID
- NCT07194265
- Acronym / sponsor ID
- PARADIGM / SP0083
- Conditions
- Severe Aortic Stenosis, Valve-in-valve Procedures
- Keywords
- tavr, severe calcific aortic stenosis, failed surgical bioprosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Anteris Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2038 (estimated)
- First posted
- 26 Sep 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.
Prospective, randomized, controlled, multicenter, international study.
Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.
After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.
Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to receive either TAVR using the DurAVR® THV System or TAVR using any commercially available and approved THV from the SAPIEN series or the Evolut series in the "All Comers Randomized Cohort"
| Arm | Type | Receives |
|---|---|---|
| DurAVR THV | Experimental | Device: TAVR with DurAVR® THVDurAVR® THV implantation |
| Control | Active comparator | Device: TAVR with SAPIEN THV series or the Evolut THV seriesSAPIEN THV series or the Evolut THV series implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
- The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
- Subject understands the study requirements and the treatment procedure and provides written informed consent.
- Severe degeneration of a surgically implanted aortic bioprosthetic valve.
- Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
Key exclusion criteria (27 listed)
- Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
- Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
- Evidence of an acute myocardial infarction 30 days before randomization.
- AV is unicuspid, Type 0 bicuspid, or is non-calcified.
- Severe total aortic regurgitation
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 |
|---|---|---|
| TAVR with DurAVR® THVTranscatheter aortic valve replacement (TAVR) | Device | DurAVR THV |
| TAVR with SAPIEN THV series or the Evolut THV seriesTranscatheter aortic valve replacement (TAVR) | Device | Control |
Primary outcome
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Time frame: 1 Year
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
5 secondary outcomes
All-cause mortality
Time frame: 30 Days
Disabling stroke according to VARC-3 Guidelines
Time frame: 30 Days
Life-threatening bleeding according to VARC-3 Guidelines
Time frame: 30 Days
Major vascular complication according to VARC-3 Guidelines
Time frame: 30 Days
Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines
Time frame: 30 Days
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 15 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR with DurAVR® THV and TAVR with SAPIEN THV series or the Evolut THV series in people with Severe Aortic Stenosis and Valve-in-valve Procedures, run by Anteris Technologies Ltd. at 1 site in Denmark.
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 8 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 15 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 1 site in Denmark. 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?
Contact Emily Neumann (+1 414 550 7619, ENeumann@anteristech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, all stroke and cardiovascular hospitalization (time frame: 1 Year). 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 15 Jul 2026.