NCT07217691

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

September 23, 2025

Last Update Submit

October 14, 2025

Conditions

Aortic StenosisTrans-catheter Aortic Valve ImplantationCommissural Alignment

Keywords

TAVICommissural alignment

Outcome Measures

Primary Outcomes (2)

  • Achievement commissural alignment.

    Proportion of patients achieving commissural alignment post-TAVI (measured by CT-analysis after TAVI).

    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.

    Day 1 (post-procedure CT)

Study Arms (2)

Standard rotation of delevery system in the descending aorta at LAO 25 degree

ACTIVE COMPARATOR

LAO 25

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

Device: Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.

Interventions

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.

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.DEVICE

In this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree.

Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe peripheral vascular disease preventing transfemoral access.
  • Prior aortic valve replacement or bicuspid valve.
  • Severely reduced kidney function (estimated glomerular filtration rate \<30).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 34538602BACKGROUND

  • 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.

    PMID: 33781722BACKGROUND

  • 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.

    PMID: 37736211BACKGROUND

  • 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.

    PMID: 34626449BACKGROUND

  • 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.

    PMID: 32381183BACKGROUND

  • 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.

    PMID: 29937429BACKGROUND

  • 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.

    PMID: 36858671BACKGROUND

  • 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.

    PMID: 35926918BACKGROUND

  • 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.

    PMID: 30121280BACKGROUND

  • 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.

    PMID: 34453165BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Ahmed Al-Ani, MD/PHD candidate

CONTACT

004792831213aalani@ous-hf.no

Trygve Hall, MD/PHD

CONTACT

004747500700tryhal@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 16, 2025

Study Start

November 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share