Aortic StenosisCOMPARE-TAVINCT06470022
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
A study testing Medtronic Evolut FX and Edwards Sapien 3 Ultra Resilia in people with Aortic Stenosis, run by Christian Juhl Terkelsen at 1 site in Denmark.
Trial summary
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Medtronic Evolut FX and Edwards Sapien 3 Ultra Resilia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,370 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Aug 2024to 20 Nov 2036
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient more than 18 years of age.
- Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.
- The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial.
- The center volume should be more than 75 cases a year.
- The patient has given signed informed consent.
- TAVI performed via the femoral artery.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of cardiology, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Read the detailed description
The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose of present study:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Hypotheses:
- Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared.
- There is no difference between valves in secondary safety and efficacy endpoints (see below)
- There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166)
- There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440).
- There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).
- Conditions
- Aortic Stenosis
- Being tested
- Medtronic Evolut FX, Edwards Sapien 3 Ultra Resilia
- 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.
Medtronic Evolut FXDevice
TAVI performed with Medtronic Evolut FX
Edwards Sapien 3 Ultra ResiliaDevice
TAVI performed with Edwards Sapien 3 Ultra Resilia
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Evolut FX | Active comparator | TAVI procedure performed with Medtronic Evolut FX Receives: Device: Medtronic Evolut FX |
| Edwards Sapien Ultra 3 Resilia | Active comparator | TAVI procedure performed with Edwards Sapien Ultra 3 Resilia Receives: Device: Edwards Sapien 3 Ultra Resilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration
The primary composite endpoint is at one-year, and a non-inferiority test is performed. See separate statistical analysis plan. Separate analyses of each component of the primary outcome will be presented, in accordance with the FDA guidelines and EMA guidelines, i.e. mortality, stroke, moderate/severe aortic regurgitation and moderate/severe THV deterioration to better understand their contribution to the primary endpoint. If non-inferiority is proven for the primary composite endpoint, a split alfa is used to test for superiority if possible (alfa=0.025) and to test secondary safety and efficacy endpoints (Total alfa=0.025 for these). The composite endpoint will be re-analyzed after 3-, 5- and 10-year as superiority analyses.
Measured: 1-year, 3-year, 5-year, 10-year
Secondary outcomes (16)
TAVI-related complications
conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade / pericardial effusion resulting in pericardiocentesis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria 10, or annulus rupture, aortic rupture/perforation, aortic dissection, or other shunts than VSD.
Measured: 7-days
Proportion with successful implantation of the chosen valve.
This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death.
Measured: 7-days
SMART criteria for bioprosthetic valve dysfunction through 12 months
composed of the following components: (1) hemodynamic structural valve dysfunction, defined as aortic valve mean gradient ≥ 20 mmHg at any time up to the 12-month visit echo; (2) nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or ≥ moderate total aortic regurgitation at any time up to the 12-month visit echo; (3) clinical valve thrombosis; (4) endocarditis; or (5) aortic valve reintervention.
Measured: 1-year
Pacemaker-implantation
New pace-maker implantation in pacemaker-naive patients.
Measured: 1-year
Vascular and access-related complications (exploratory only)
Major vascular access site and access-related complications resulting in endovascular or open surgery using VARC-3 criteria
Measured: 30-days
Bleeding and transfusion (exploratory only)
Major bleeding resulting in drop in hgb-level ≥1.86 mmol/l and/or erythrocyte transfusion ≥ 2 units, modified from BARC type 3-5 criteria
Measured: 30-days
Endocarditis (exploratory only)
According to VARC-3 criteria.
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Reoperation (exploratory only)
Transcatheter Aortic Valve Intervention, Surgical Aortic Valve Intervention or Balloon Angioplasty
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Moderate/severe prosthesis-patient mismatch (exploratory only)
Effective Orifice Area (EOA)/body surface area ≤0.85 cm2/m2 if BMI<30 kg/cm2 or <=0.70 cm2/m2 if BMI>=30 kg/cm2., according to VARC-3 criteria.
Measured: 30-day
Mean gradient (exploratory only)
Aortic mean gradient, mmHg, as evaluated by Echocardiograpy Core-laboratory.
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Pacemaker-implantation (exploratory only)
New pacemaker in pacemaker naive-patients.
Measured: 30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year
Readmission for congestive heart failure (exploratory only)
Adjudicated. Only monitored until first confirmed case.
Measured: 30-day, 1-year, 3-year, 5-year, 10-year.
AMI (exploratory only)
Acute Myocardial Infarction. Adjudicated. Only monitored until first confirmed case.
Measured: 30-day, 1-year, 3-year, 5-year, 10-year.
Revascularization (exploratory only)
PCI (Percutaneous coronary intervention) CABG (Coronary Artery Bypass Grafting), not scheduled before TAVI
Measured: 30-day, 1-year, 3-year, 5-year, 10-year.
Atrial fibrillation (exploratory only)
Newly diagnosed atrial fibrillation/flutter
Measured: 30-day, 1-year, 3-year, 5-year, 10-year.
Kidney injury (exploratory only)
Increase in renal creatinine level more than to ≥200% (AKIN stage 2-3, VARC-3 criteria) or resulting in dialysis (AKIN stage 4) according to VARC-3 criteria.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start9 Aug 2024
- Primary completion14 Jul 2027 (estimated)
- Study completion20 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomized 1:1
- Masking
- None (open label)
- Enrolment
- 1,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Juhl Terkelsen
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
- Responsible party
- Sponsor-investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
- Investigators
- christian J Terkelsen, Professor, Principal investigator, Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470022
- Sponsor's protocol ID
- COMPARE-TAVI-2
- Acronym
- COMPARE-TAVI
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We are willing to collaborate in meta-analyses based on individual data where department of epidemiology, Aarhus University Hospital will be responsible for data-analyses.
Publications
Thim T, Nissen H, Niemela M, Eftekhari A, Jalanko M, Savontaus M, Jaaskelainen P, Hensey M, Jensen RV, Norgaard BL, Frederiksen CA, Vase HO, Pedersen L, Sorensen HT, Christiansen EH, Terkelsen CJ. Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves. Am Heart J. 2026 Jul;297:107387. doi: 10.1016/j.ahj.2026.107387. Epub 2026 Feb 23.
PubMed 41740661
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
- ClinicalTrials.gov ID
- NCT06470022
- Acronym / sponsor ID
- COMPARE-TAVI / COMPARE-TAVI-2
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,370 participants (actual)
- Lead sponsor
- Christian Juhl TerkelsenUniversity, hospital or other
- Collaborators
- Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 20 Nov 2036 (estimated)
- First posted
- 24 Jun 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.
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Detailed description
The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose of present study:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Hypotheses:
- Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared.
- There is no difference between valves in secondary safety and efficacy endpoints (see below)
- There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166)
- There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440).
- There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Medtronic Evolut FX | Active comparator | Device: Medtronic Evolut FXTAVI procedure performed with Medtronic Evolut FX |
| Edwards Sapien Ultra 3 Resilia | Active comparator | Device: Edwards Sapien 3 Ultra ResiliaTAVI procedure performed with Edwards Sapien Ultra 3 Resilia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient more than 18 years of age.
- Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.
- The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial.
- The center volume should be more than 75 cases a year.
- The patient has given signed informed consent.
Key exclusion criteria (1 listed)
- None
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 Evolut FXTAVI performed with Medtronic Evolut FX | Device | Medtronic Evolut FX |
| Edwards Sapien 3 Ultra ResiliaTAVI performed with Edwards Sapien 3 Ultra Resilia | Device | Edwards Sapien Ultra 3 Resilia |
Primary outcome
Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration
Time frame: 1-year, 3-year, 5-year, 10-year
The primary composite endpoint is at one-year, and a non-inferiority test is performed. See separate statistical analysis plan. Separate analyses of each component of the primary outcome will be presented, in accordance with the FDA guidelines and EMA guidelines, i.e. mortality, stroke, moderate/severe aortic regurgitation and moderate/severe THV deterioration to better understand their contribution to the primary endpoint. If non-inferiority is proven for the primary composite endpoint, a split alfa is used to test for superiority if possible (alfa=0.025) and to test secondary safety and efficacy endpoints (Total alfa=0.025 for these). The composite endpoint will be re-analyzed after 3-, 5- and 10-year as superiority analyses.
16 secondary outcomes
TAVI-related complications
Time frame: 7-days
Proportion with successful implantation of the chosen valve.
Time frame: 7-days
SMART criteria for bioprosthetic valve dysfunction through 12 months
Time frame: 1-year
Pacemaker-implantation
Time frame: 1-year
Vascular and access-related complications (exploratory only)
Time frame: 30-days
Bleeding and transfusion (exploratory only)
Time frame: 30-days
Endocarditis (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Reoperation (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Moderate/severe prosthesis-patient mismatch (exploratory only)
Time frame: 30-day
Mean gradient (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Pacemaker-implantation (exploratory only)
Time frame: 30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year
Readmission for congestive heart failure (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year.
AMI (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year.
Revascularization (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year.
Atrial fibrillation (exploratory only)
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year.
Kidney injury (exploratory only)
Time frame: 30-day
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 25 Aug 2026.
- Derived from this study: PubMed 41740661Thim T, Nissen H, Niemela M, Eftekhari A, Jalanko M, Savontaus M, Jaaskelainen P, Hensey M, Jensen RV, Norgaard BL, Frederiksen CA, Vase HO, Pedersen L, Sorensen HT, Christiansen EH, Terkelsen CJ. Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves. Am Heart J. 2026 Jul;297:107387. doi: 10.1016/j.ahj.2026.107387. Epub 2026 Feb 23.
- Individual participant dataSharing planned: Yes. We are willing to collaborate in meta-analyses based on individual data where department of epidemiology, Aarhus University Hospital will be responsible for data-analyses.
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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.
christian J Terkelsen, Professor principal investigator
Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Evolut FX and Edwards Sapien 3 Ultra Resilia in people with Aortic Stenosis, run by Christian Juhl Terkelsen 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 6 inclusion and 1 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 25 Aug 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?
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?
Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration (time frame: 1-year, 3-year, 5-year, 10-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06470022, which also lists 1 linked publication.
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 25 Aug 2026.