Aortic Valve StenosisDOUBLE-CHOICENCT05036018
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
A study testing ACURATE neo2, minimalist approach and CoreValve Evolut Pro, Pro+ and FX in people with Aortic Valve Stenosis, run by Leipzig Heart Science gGmbH at 10 sites in Germany.
Trial summary
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- ACURATE neo2, minimalist approach and CoreValve Evolut Pro, Pro+ and FX
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 836 participants
- Where
- 10 sitesGermany
- Study dates
- 30 Aug 2021to 1 Feb 2035
- 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
- Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
- Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
- Heart team consensus that the patient is anatomically suitable for both device types
- Suitability for transfemoral vascular access
- Written informed consent
Who cannot join
- Life expectancy <12 months due to comorbidities
- Native aortic valve annulus <21 mm and >27 mm
- Bicuspid aortic valve
- Cardiogenic shock or hemodynamic instability
- Active endocarditis
- Contraindications for transfemoral access
Show all 13Show fewer
- Active peptic ulcer or upper gastro-intestinal bleeding <2 weeks
- Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
- Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
- Active infection requiring antibiotic treatment
- Age <18 years
- Participation in another interventional trial where the primary endpoint has not been reached
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Zentralklinik Bad Berka
Bad Berka, 99437
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Universitätsklinikum Köln
Cologne, 50937
St.-Johannes-Hospital Dortmund
Dortmund, 44137
Universitätsklinikum Gießen
Giessen, 35392
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289
Herzzentrum München
München, 80636
LMU Klinikum München
München, 81377
Universitätsklinikum Tübingen
Tübingen, 72076
Helios Klinikum Wuppertal
Wuppertal, 42283
About this study
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
Read the detailed description
The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro, Pro+ and FX, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI.
- Conditions
- Aortic Valve Stenosis
- Being tested
- ACURATE neo2, minimalist approach, CoreValve Evolut Pro, Pro+ and FX, Standard of care
- Keywords
- TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach
- 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.
ACURATE neo2Device
The ACURATE neo2 valve will be implanted using a two-step mechanism during transfemoral transcatheter aortic valve implantation (TAVI). Balloon predilatation will be recommended in the ACURATE neo 2 valve group.
minimalist approachProcedure or surgery
Isolated local anesthesia. Central venous lines, additional arterial lines for blood pressure monitoring, and urinary catheters will be avoided. Insertion of temporary pacemakers is optional and should be avoided whenever possible, and peri-procedural pacing can then be performed on the left ventricular wire. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.
CoreValve Evolut Pro, Pro+ and FXDevice
The Evolut Pro, Pro+ or FX valve is positioned in a controlled manner either without pacing or under 'slow-rapid' pacing with allowance for limited repositioning and is anchored to the annulus and ascending aorta.
Standard of careProcedure or surgery
Sedation should be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -2 according to local standard of care.The use of EEG monitoring (i.e. BIS, Sedline) can be applied. Continuous CO2-monitoring via face mask should be established during sedation. All patients will receive supplemental oxygen by face mask to maintain an oxygen saturation of approximately 95%. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients treated with the ACURATE neo2 valve using a minimalist approach Receives: Device: ACURATE neo2; Procedure: minimalist approach |
| Group 2 | Active comparator | Patients treated with the ACURATE neo2 valve under standard of care Receives: Device: ACURATE neo2; Procedure: Standard of care |
| Group 3 | Active comparator | Patients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach Receives: Procedure: minimalist approach; Device: CoreValve Evolut Pro, Pro+ and FX |
| Group 4 | Active comparator | Patients treated with the Evolut Pro, Pro+ or FX valve under standard of care Receives: Device: CoreValve Evolut Pro, Pro+ and FX; Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
Measured: Day 30
Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start30 Aug 2021
- Primary completion31 Mar 2025
- Study completion1 Feb 2035 (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 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
- Randomised
- Intervention model
- Factorial
- Model description
- Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
- Masking
- None (open label)
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, Prof. Dr., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036018
- Sponsor's protocol ID
- 2021-0165
- Acronym
- DOUBLE-CHOICE
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feistritzer HJ, Ender J, Lauten P, Rudolph TK, Rudolph V, Geisler T, Massberg S, Adam M, Baldus S, Sossalla S, Joner M, Mollmann H, Wolf A, Kim WK, Borger MA, Noack T, Magunia H, von Dossow V, Sander M, Vigelius-Rauch U, Feuerecker M, Zakhary W, Boening A, Bleiziffer S, Hohenstein S, Hoesler N, Buske M, Desch S, Abdel-Wahab M, Thiele H; DOUBLE-CHOICE Investigators. Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. 2025 Dec 2;152(22):1526-1537. doi: 10.1161/CIRCULATIONAHA.125.076557. Epub 2025 Aug 29.
PubMed 40878766
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05036018
- Acronym / sponsor ID
- DOUBLE-CHOICE / 2021-0165
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 836 participants (actual)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Feb 2035 (estimated)
- First posted
- 5 Sep 2021 (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.
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
Detailed description
The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro, Pro+ and FX, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: ACURATE neo2, Procedure: minimalist approachPatients treated with the ACURATE neo2 valve using a minimalist approach |
| Group 2 | Active comparator | Device: ACURATE neo2, Procedure: Standard of carePatients treated with the ACURATE neo2 valve under standard of care |
| Group 3 | Active comparator | Procedure: minimalist approach, Device: CoreValve Evolut Pro, Pro+ and FXPatients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach |
| Group 4 | Active comparator | Device: CoreValve Evolut Pro, Pro+ and FX, Procedure: Standard of carePatients treated with the Evolut Pro, Pro+ or FX valve under standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
- Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
- Heart team consensus that the patient is anatomically suitable for both device types
- Suitability for transfemoral vascular access
- Written informed consent
Key exclusion criteria (13 listed)
- Life expectancy <12 months due to comorbidities
- Native aortic valve annulus <21 mm and >27 mm
- Bicuspid aortic valve
- Cardiogenic shock or hemodynamic instability
- Active endocarditis
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 |
|---|---|---|
| ACURATE neo2The ACURATE neo2 valve will be implanted using a two-step mechanism during transfemoral transcatheter aortic valve implantation (TAVI). Balloon predilatation will be recommended in the ACURATE neo 2 valve group. | Device | Group 1, Group 2 |
| minimalist approachIsolated local anesthesia. Central venous lines, additional arterial lines for blood pressure monitoring, and urinary catheters will be avoided. Insertion of temporary pacemakers is optional and should be avoided whenever possible, and peri-procedural pacing can then be performed on the left ventricular wire. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications. | Procedure or surgery | Group 1, Group 3 |
| CoreValve Evolut Pro, Pro+ and FXThe Evolut Pro, Pro+ or FX valve is positioned in a controlled manner either without pacing or under 'slow-rapid' pacing with allowance for limited repositioning and is anchored to the annulus and ascending aorta. | Device | Group 3, Group 4 |
| Standard of careSedation should be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -2 according to local standard of care.The use of EEG monitoring (i.e. BIS, Sedline) can be applied. Continuous CO2-monitoring via face mask should be established during sedation. All patients will receive supplemental oxygen by face mask to maintain an oxygen saturation of approximately 95%. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards. | Procedure or surgery | Group 2, Group 4 |
Primary outcome
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
Time frame: Day 30
Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)
Time frame: Day 30
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 11 Feb 2026.
- Derived from this study: PubMed 40878766Feistritzer HJ, Ender J, Lauten P, Rudolph TK, Rudolph V, Geisler T, Massberg S, Adam M, Baldus S, Sossalla S, Joner M, Mollmann H, Wolf A, Kim WK, Borger MA, Noack T, Magunia H, von Dossow V, Sander M, Vigelius-Rauch U, Feuerecker M, Zakhary W, Boening A, Bleiziffer S, Hohenstein S, Hoesler N, Buske M, Desch S, Abdel-Wahab M, Thiele H; DOUBLE-CHOICE Investigators. Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. 2025 Dec 2;152(22):1526-1537. doi: 10.1161/CIRCULATIONAHA.125.076557. Epub 2025 Aug 29.
- 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.
Holger Thiele, Prof. Dr. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACURATE neo2, minimalist approach and CoreValve Evolut Pro, Pro+ and FX in people with Aortic Valve Stenosis, run by Leipzig Heart Science gGmbH at 10 sites in Germany.
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 13 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up (time frame: Day 30). The study lists 2 primary outcomes in all. 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 NCT05036018, 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 11 Feb 2026.