Aortic StenosisALIGN-EFXNCT07217691
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
A study testing Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25 and Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree. in people with Aortic Stenosis and Trans-catheter Aortic Valve Implantation, run by Oslo University Hospital.
Trial summary
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation. Method The study will include patients undergoing TAVI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Commissural Alignment
- What is being tested?
- Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25 and Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe aortic stenosis indicated for TAVI after heart team meeting.
- Age ≥65 years.
- Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).
- Patients providing informed consent.
Who cannot join
- Severe peripheral vascular disease preventing transfemoral access.
- Prior aortic valve replacement or bicuspid valve.
- Severely reduced kidney function (estimated glomerular filtration rate <30).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation.
Method The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice.
Read more
Examinations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice.
Significance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.
Read the detailed description
The purpose of the present study is to prospectively evaluate the efficacy and safety of a novel patient-specific rotation of the Evolut FX+ TAVI valve and the delivering system during the transfemoral (TF) procedure. Specifically, it aims to evaluate and compare the commonly used fluoroscopic (X-ray) LAO degree for rotation of the delivery system and more patient-specific LAO degree achieved by CT analysis prior to the procedure. The degree of alignment and coronary overlap will be measured with ECG-gated CT after the procedure. Thus, it will prospectively explore if these two techniques differ in obtaining commissural alignment, coronary overlap and safety outcomes following implantation of latest-generation Evolut FX+ valve.
We intend to include 40 patients with severe aortic stenosis and in whom TF-TAVI with Evolut FX+ is planned after heart team meeting. Preprocedure CT scan and postprocedure CT scan will be evaluated for commissural alignment.
- Being tested
- Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25, Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.
- Keywords
- TAVI, Commissural alignment
- 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.
Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25Device
In this arm the HAT marker will be placed in the outer curvature of descending aorta in LAO 25 degree.
Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.Device
In this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree.
| Study group | Role | What they receive |
|---|---|---|
| Standard rotation of delevery system in the descending aorta at LAO 25 degree | Active comparator | LAO 25 Receives: Device: Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25 |
| Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT | Active comparator | Patient specific degree Receives: Device: Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement commissural alignment.
Proportion of patients achieving commissural alignment post-TAVI (measured by CT-analysis after TAVI).
Measured: Day 1 (post-procedure CT).
Commissural alignment after TAVI measured in degrees.
Commissural alignment following TAVI, assessed by computed tomography (CT) analysis.
Native commissures (measured before TAVI from CT) will serve as the reference. We will measure the number of degrees of all three commissures from the center of the left main artery before and after TAVI to estimate alignment.
Measured: Day 1 (post-procedure CT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Al-Ani, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217691
- Sponsor's protocol ID
- 904586
- Acronym
- ALIGN-EFX
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15.
PubMed 34538602Redondo A, Valencia-Serrano F, Santos-Martinez S, Delgado-Arana JR, Barrero A, Serrador A, Gutierrez H, Sanchez-Lite I, Sevilla T, Revilla A, Baladron C, Kim WK, Carrasco-Moraleja M, San Roman JA, Amat-Santos IJ. Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept. Rev Esp Cardiol (Engl Ed). 2022 Mar;75(3):203-212. doi: 10.1016/j.rec.2021.02.004. Epub 2021 Mar 26. English, Spanish.
PubMed 33781722Konami Y, Sakamoto T, Suzuyama H, Horio E, Yamaguchi J. Commissural alignment in the Evolut TAVR procedure: conventional versus hat marker-guided shaft rotation methods. AsiaIntervention. 2023 Sep 21;9(2):156-165. doi: 10.4244/AIJ-D-23-00017. eCollection 2023 Sep.
PubMed 37736211Tang GHL, Sengupta A, Alexis SL, Zaid S, Leipsic JA, Blanke P, Grubb KJ, Gada H, Yakubov SJ, Rogers T, Lerakis S, Khera S, Adams DH, Sharma SK, Kini A, Reardon MJ. Conventional versus modified delivery system technique in commissural alignment from the Evolut low-risk CT substudy. Catheter Cardiovasc Interv. 2022 Feb;99(3):924-931. doi: 10.1002/ccd.29973. Epub 2021 Oct 9.
PubMed 34626449Jilaihawi H. When the (Commissural) Stars (Mis)ALIGN. JACC Cardiovasc Interv. 2020 May 11;13(9):1043-1045. doi: 10.1016/j.jcin.2020.03.001. Epub 2020 Mar 16. No abstract available.
PubMed 32381183Sondergaard L, De Backer O. Transcatheter aortic valve implantation: don't forget the coronary arteries! EuroIntervention. 2018 Jun 20;14(2):147-149. doi: 10.4244/EIJV14I2A24. No abstract available.
PubMed 29937429Khera S, Krishnamoorthy P, Sharma SK, Kini AS, Dangas GD, Goel S, Lerakis S, Anastasius M, Moreno P, Tang GHL. Improved Commissural Alignment in TAVR With the Newest Evolut FX Self-Expanding Supra-Annular Valve: First-in-Human Experience. JACC Cardiovasc Interv. 2023 Feb 27;16(4):498-500. doi: 10.1016/j.jcin.2022.10.041. Epub 2022 Nov 16. No abstract available.
PubMed 36858671Tang GHL, Amat-Santos IJ, De Backer O, Avvedimento M, Redondo A, Barbanti M, Costa G, Tchetche D, Eltchaninoff H, Kim WK, Zaid S, Tarantini G, Sondergaard L. Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1497-1518. doi: 10.1016/j.jcin.2022.06.001.
PubMed 35926918Fuchs A, Kofoed KF, Yoon SH, Schaffner Y, Bieliauskas G, Thyregod HG, Makkar R, Sondergaard L, De Backer O, Bapat V. Commissural Alignment of Bioprosthetic Aortic Valve and Native Aortic Valve Following Surgical and Transcatheter Aortic Valve Replacement and its Impact on Valvular Function and Coronary Filling. JACC Cardiovasc Interv. 2018 Sep 10;11(17):1733-1743. doi: 10.1016/j.jcin.2018.05.043. Epub 2018 Aug 15.
PubMed 30121280Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.
- ClinicalTrials.gov ID
- NCT07217691
- Acronym / sponsor ID
- ALIGN-EFX / 904586
- Keywords
- TAVI, Commissural alignment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Oct 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.
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation.
Method The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice.
Examinations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice.
Significance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.
Detailed description
The purpose of the present study is to prospectively evaluate the efficacy and safety of a novel patient-specific rotation of the Evolut FX+ TAVI valve and the delivering system during the transfemoral (TF) procedure. Specifically, it aims to evaluate and compare the commonly used fluoroscopic (X-ray) LAO degree for rotation of the delivery system and more patient-specific LAO degree achieved by CT analysis prior to the procedure. The degree of alignment and coronary overlap will be measured with ECG-gated CT after the procedure. Thus, it will prospectively explore if these two techniques differ in obtaining commissural alignment, coronary overlap and safety outcomes following implantation of latest-generation Evolut FX+ valve.
We intend to include 40 patients with severe aortic stenosis and in whom TF-TAVI with Evolut FX+ is planned after heart team meeting. Preprocedure CT scan and postprocedure CT scan will be evaluated for commissural alignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rotation of delevery system in the descending aorta at LAO 25 degree | Active comparator | Device: Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25LAO 25 |
| Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT | Active comparator | Device: Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.Patient specific degree |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with severe aortic stenosis indicated for TAVI after heart team meeting.
- Age ≥65 years.
- Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).
- Patients providing informed consent.
Key exclusion criteria (3 listed)
- Severe peripheral vascular disease preventing transfemoral access.
- Prior aortic valve replacement or bicuspid valve.
- Severely reduced kidney function (estimated glomerular filtration rate <30).
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 |
|---|---|---|
| Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25In this arm the HAT marker will be placed in the outer curvature of descending aorta in LAO 25 degree. | Device | Standard rotation of delevery system in the descending aorta at LAO 25 degree |
| Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.In this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree. | Device | Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT |
Primary outcome
Achievement commissural alignment.
Time frame: Day 1 (post-procedure CT).
Proportion of patients achieving commissural alignment post-TAVI (measured by CT-analysis after TAVI).
Commissural alignment after TAVI measured in degrees.
Time frame: Day 1 (post-procedure CT)
Commissural alignment following TAVI, assessed by computed tomography (CT) analysis. Native commissures (measured before TAVI from CT) will serve as the reference. We will measure the number of degrees of all three commissures from the center of the left main artery before and after TAVI to estimate alignment.
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 16 Oct 2025.
- Background: PubMed 34538602Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15.
- Background: PubMed 33781722Redondo A, Valencia-Serrano F, Santos-Martinez S, Delgado-Arana JR, Barrero A, Serrador A, Gutierrez H, Sanchez-Lite I, Sevilla T, Revilla A, Baladron C, Kim WK, Carrasco-Moraleja M, San Roman JA, Amat-Santos IJ. Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept. Rev Esp Cardiol (Engl Ed). 2022 Mar;75(3):203-212. doi: 10.1016/j.rec.2021.02.004. Epub 2021 Mar 26. English, Spanish.
- Background: PubMed 37736211Konami Y, Sakamoto T, Suzuyama H, Horio E, Yamaguchi J. Commissural alignment in the Evolut TAVR procedure: conventional versus hat marker-guided shaft rotation methods. AsiaIntervention. 2023 Sep 21;9(2):156-165. doi: 10.4244/AIJ-D-23-00017. eCollection 2023 Sep.
- Background: PubMed 34626449Tang GHL, Sengupta A, Alexis SL, Zaid S, Leipsic JA, Blanke P, Grubb KJ, Gada H, Yakubov SJ, Rogers T, Lerakis S, Khera S, Adams DH, Sharma SK, Kini A, Reardon MJ. Conventional versus modified delivery system technique in commissural alignment from the Evolut low-risk CT substudy. Catheter Cardiovasc Interv. 2022 Feb;99(3):924-931. doi: 10.1002/ccd.29973. Epub 2021 Oct 9.
- Background: PubMed 32381183Jilaihawi H. When the (Commissural) Stars (Mis)ALIGN. JACC Cardiovasc Interv. 2020 May 11;13(9):1043-1045. doi: 10.1016/j.jcin.2020.03.001. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 29937429Sondergaard L, De Backer O. Transcatheter aortic valve implantation: don't forget the coronary arteries! EuroIntervention. 2018 Jun 20;14(2):147-149. doi: 10.4244/EIJV14I2A24. No abstract available.
- Background: PubMed 36858671Khera S, Krishnamoorthy P, Sharma SK, Kini AS, Dangas GD, Goel S, Lerakis S, Anastasius M, Moreno P, Tang GHL. Improved Commissural Alignment in TAVR With the Newest Evolut FX Self-Expanding Supra-Annular Valve: First-in-Human Experience. JACC Cardiovasc Interv. 2023 Feb 27;16(4):498-500. doi: 10.1016/j.jcin.2022.10.041. Epub 2022 Nov 16. No abstract available.
- Background: PubMed 35926918Tang GHL, Amat-Santos IJ, De Backer O, Avvedimento M, Redondo A, Barbanti M, Costa G, Tchetche D, Eltchaninoff H, Kim WK, Zaid S, Tarantini G, Sondergaard L. Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1497-1518. doi: 10.1016/j.jcin.2022.06.001.
- Background: PubMed 30121280Fuchs A, Kofoed KF, Yoon SH, Schaffner Y, Bieliauskas G, Thyregod HG, Makkar R, Sondergaard L, De Backer O, Bapat V. Commissural Alignment of Bioprosthetic Aortic Valve and Native Aortic Valve Following Surgical and Transcatheter Aortic Valve Replacement and its Impact on Valvular Function and Coronary Filling. JACC Cardiovasc Interv. 2018 Sep 10;11(17):1733-1743. doi: 10.1016/j.jcin.2018.05.043. Epub 2018 Aug 15.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25 and Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree. in people with Aortic Stenosis and Trans-catheter Aortic Valve Implantation, run by Oslo University Hospital.
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 4 inclusion and 3 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 16 Oct 2025. 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?
Contact Ahmed Al-Ani, MD/PHD candidate (004792831213, aalani@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement commissural alignment. (time frame: Day 1 (post-procedure CT).). 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 NCT07217691, which also lists 10 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 16 Oct 2025.