Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
NCT ID: NCT07217691
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-11-01
2026-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard rotation of delevery system in the descending aorta at LAO 25 degree
LAO 25
Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25
In this arm the HAT marker will be placed in the outer curvature of descending aorta in LAO 25 degree.
Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT
Patient specific 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.
Interventions
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Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25
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.
In this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree.
Eligibility Criteria
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Inclusion Criteria
* Age ≥65 years.
* Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).
* Patients providing informed consent.
Exclusion Criteria
* Prior aortic valve replacement or bicuspid valve.
* Severely reduced kidney function (estimated glomerular filtration rate \<30).
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Ahmed Al-Ani
MD
Central Contacts
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References
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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.
Redondo 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.
Konami 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.
Tang 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.
Jilaihawi 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.
Sondergaard 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.
Khera 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.
Tang 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.
Fuchs 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.
Vahanian 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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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904586
Identifier Type: -
Identifier Source: org_study_id
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