Transcatheter Aortic Valve ImplantationCompare-TAVINCT04443023
Comparison of Eligible TAVI-valves - Cohort B
A study testing chosen TAVI valve in people with Transcatheter Aortic Valve Implantation, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation
- What is being tested?
- chosen TAVI valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,031 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2020to 2 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient more than 18 years of age.
- Patient eligible for at least 2 valves being implanted routinely at the participating center, 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 at least 15 valves implanted before a valve can be 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
- 1. Not able to give written inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
Read the detailed description
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve.
Hypotheses:
- There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared.
- There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.
Design: Randomized controlled trial with clinical national registry follow-up.
Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria.
Randomization:
Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves.
Consecutive cohorts are established.
In the current study we plan to initiate the following cohorts:
Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.
Operator requirements:
Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.
- Conditions
- Transcatheter Aortic Valve Implantation
- Being tested
- chosen TAVI valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chosen TAVI valveDevice
chosen TAVI valve
| Study group | Role | What they receive |
|---|---|---|
| Sapien | Active comparator | Patients randomized to treatment Receives: Device: chosen TAVI valve |
| Myval | Active comparator | Patients randomized to treatment Receives: Device: chosen TAVI valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with MACE (Major Adverse Cardiovascular Events)
Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
Measured: 1 year
Secondary outcomes (26)
Percentage of patients with MACE
Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
Measured: 30 day, 3-year, 5-year and 10-year
Percentage death
Mortality
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with stroke
According to Valve Academic Research Consortium (VARC)-3 criteria
Measured: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate or severe paravalvular leakage
Moderate or severe paravalvular leakage according to VARC-3 criteria
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate/major aortic stenosis
According to VARC-3 criteria
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with new pacemaker
New Pacemaker after TAVI-procedure
Measured: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with major bleeding
Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg>=1.86 mmol/l or >=2 units of blood transfusion
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Distance in meters during 6-minute walk test
6-minute walk test
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with other 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, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria
Measured: During TAVI-procedure
Percentage of patients with endocarditis
Endocarditis
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
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: During procedure
Percentage of patients with major vascular access site and access-related complications
According to VARC-3 criteria
Measured: During admission and 30-day
Percentage of patients with valve thrombosis or severe stenosis
Valve thrombosis or severe stenosis confirmed by Echo or HCT
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with readmission with congestive heart failure
Readmission with congestive heart failure
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with increase in creatinin level of 100% or more, or dialysis
Increase in renal creatinine level more than to >=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis
Measured: during admission and within 30 days
Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups
Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)
Measured: 30-day
Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups
Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)
Measured: 30-day
Percentage of patients with prosthesis-patient mismatch
Prosthesis-patient mismatch (EOA/body surface area). Severe PPM≤0.65 cm2/m2. Moderate PPM≤0.85 cm2/m2 according to VARC-3 criteria
Measured: 30-day, 1-year, 3-year, 5-year, 10-year
Mean effective orifice area measured by MRI
Effective orifice area measured by MRI in patients participating in MRI-substudy
Measured: 30-day
Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT
Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy
Measured: 30-day and 1-year
Mean volume of aortic regurgitation measured by MRI
Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy
Measured: 30-day
Other tavi-related complications
Anulus rupture or aortic rupture
Measured: 30-day
AMI
Acute Myocardial Infarction
Measured: 30-day, 1-year, 3-year, 5-year and 10-year
PCI og CABG
Percutaneous Coronary Intervention or coronary artery bypass grafting
Measured: 30-day, 1-year, 3-year, 5-year and 10-year
Reopeation
Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria
Measured: 30-day, 1-year, 3-year, 5-year and 10-year
Afib
Newly diagnosed atrial fibrillation according to VARC-3 criteria
Measured: 30-day, 1-year, 3-year, 5-year and 10-year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start15 Jun 2020
- Primary completion2 Nov 2023
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ImplantationStudies 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
- Masking
- None (open label)
- Enrolment
- 1,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
- Investigators
- henrik nissen, PhD, Study chair, odense univeristy hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443023
- Sponsor's protocol ID
- Compare-TAVI
- Acronym
- Compare-TAVI
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2020
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.
Publications
Terkelsen CJ, Thim T, Freeman P, Dahl JS, Norgaard BL, Kim WY, Tang M, Sorensen HT, Christiansen EH, Nissen H. Randomized comparison of TAVI valves: The Compare-TAVI trial. Am Heart J. 2024 Aug;274:84-94. doi: 10.1016/j.ahj.2024.05.003. Epub 2024 May 9.
PubMed 38729550Thim T, Nissen H, Freeman P, Dahl JS, Christiansen EH, Norsell M, Eftekhari A, Norgaard BL, Frederiksen CA, Vase HO, Ellert J, Ovrehus KA, Tang M, Terkelsen CJ. Transcatheter aortic valve implantation in patients with tricuspid, bicuspid and bioprosthetic valves: observations from COMPARE-TAVI 1. Scand Cardiovasc J. 2026 Sep 18:1-11. doi: 10.1080/14017431.2026.2704938. Online ahead of print.
PubMed 42757819Thim T, Nissen H, Freeman P, Sanchez Dahl J, Christiansen EH, Eftekhari A, Linde Norgaard B, Povlsen JA, Poulsen SH, Jensen RV, Ovrehus KA, Terkelsen CJ. Transcatheter aortic valve implantation outcomes by patient age and sex in COMPARE-TAVI 1: a cohort study. BMJ Open. 2026 Jul 10;16(7):e121596. doi: 10.1136/bmjopen-2026-121596.
PubMed 42431661Terkelsen CJ, Freeman P, Dahl JS, Thim T, Norgaard BL, Mogensen NSB, Tang M, Eftekhari A, Povlsen JA, Poulsen SH, Pedersen L, Hjort J, Ellert J, Christiansen EH, Sorensen HT, Nissen H. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial. Lancet. 2025 Apr 19;405(10487):1362-1372. doi: 10.1016/S0140-6736(25)00106-0. Epub 2025 Apr 2.
PubMed 40187364
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)
- ClinicalTrials.gov ID
- NCT04443023
- Acronym / sponsor ID
- Compare-TAVI / Compare-TAVI
- Conditions
- Transcatheter Aortic Valve Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,031 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 23 Jun 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.
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
Detailed description
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve.
Hypotheses:
- There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared.
- There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.
Design: Randomized controlled trial with clinical national registry follow-up.
Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria.
Randomization:
Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves.
Consecutive cohorts are established.
In the current study we plan to initiate the following cohorts:
Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.
Operator requirements:
Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sapien | Active comparator | Device: chosen TAVI valvePatients randomized to treatment |
| Myval | Active comparator | Device: chosen TAVI valvePatients randomized to treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient more than 18 years of age.
- Patient eligible for at least 2 valves being implanted routinely at the participating center, 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 at least 15 valves implanted before a valve can be 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)
- 1. Not able to give written inform consent
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 |
|---|---|---|
| chosen TAVI valvechosen TAVI valve | Device | Myval, Sapien |
Primary outcome
Percentage of patients with MACE (Major Adverse Cardiovascular Events)
Time frame: 1 year
Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
26 secondary outcomes
Percentage of patients with MACE
Time frame: 30 day, 3-year, 5-year and 10-year
Percentage death
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with stroke
Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate or severe paravalvular leakage
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate/major aortic stenosis
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with new pacemaker
Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with major bleeding
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Distance in meters during 6-minute walk test
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with other TAVI-related complications
Time frame: During TAVI-procedure
Percentage of patients with endocarditis
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Proportion with successful implantation of the chosen valve.
Time frame: During procedure
Percentage of patients with major vascular access site and access-related complications
Time frame: During admission and 30-day
Percentage of patients with valve thrombosis or severe stenosis
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with readmission with congestive heart failure
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with increase in creatinin level of 100% or more, or dialysis
Time frame: during admission and within 30 days
Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups
Time frame: 30-day
Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups
Time frame: 30-day
Percentage of patients with prosthesis-patient mismatch
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Mean effective orifice area measured by MRI
Time frame: 30-day
Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT
Time frame: 30-day and 1-year
Mean volume of aortic regurgitation measured by MRI
Time frame: 30-day
Other tavi-related complications
Time frame: 30-day
AMI
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
PCI og CABG
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
Reopeation
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
Afib
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 38729550Terkelsen CJ, Thim T, Freeman P, Dahl JS, Norgaard BL, Kim WY, Tang M, Sorensen HT, Christiansen EH, Nissen H. Randomized comparison of TAVI valves: The Compare-TAVI trial. Am Heart J. 2024 Aug;274:84-94. doi: 10.1016/j.ahj.2024.05.003. Epub 2024 May 9.
- Derived from this study: PubMed 42757819Thim T, Nissen H, Freeman P, Dahl JS, Christiansen EH, Norsell M, Eftekhari A, Norgaard BL, Frederiksen CA, Vase HO, Ellert J, Ovrehus KA, Tang M, Terkelsen CJ. Transcatheter aortic valve implantation in patients with tricuspid, bicuspid and bioprosthetic valves: observations from COMPARE-TAVI 1. Scand Cardiovasc J. 2026 Sep 18:1-11. doi: 10.1080/14017431.2026.2704938. Online ahead of print.
- Derived from this study: PubMed 42431661Thim T, Nissen H, Freeman P, Sanchez Dahl J, Christiansen EH, Eftekhari A, Linde Norgaard B, Povlsen JA, Poulsen SH, Jensen RV, Ovrehus KA, Terkelsen CJ. Transcatheter aortic valve implantation outcomes by patient age and sex in COMPARE-TAVI 1: a cohort study. BMJ Open. 2026 Jul 10;16(7):e121596. doi: 10.1136/bmjopen-2026-121596.
- Derived from this study: PubMed 40187364Terkelsen CJ, Freeman P, Dahl JS, Thim T, Norgaard BL, Mogensen NSB, Tang M, Eftekhari A, Povlsen JA, Poulsen SH, Pedersen L, Hjort J, Ellert J, Christiansen EH, Sorensen HT, Nissen H. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial. Lancet. 2025 Apr 19;405(10487):1362-1372. doi: 10.1016/S0140-6736(25)00106-0. Epub 2025 Apr 2.
- Individual participant dataSharing planned: Yes. Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.
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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.
henrik nissen, PhD study chair
odense univeristy hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chosen TAVI valve in people with Transcatheter Aortic Valve Implantation, run by Aarhus University Hospital Skejby 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: finished, as of the sponsor's last update on 23 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with MACE (Major Adverse Cardiovascular Events) (time frame: 1 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 NCT04443023, which also lists 4 linked publications.
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 23 Apr 2026.