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NCT Number: NCT07217691

Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Commissural Alignment Heart Diseases Heart Valve Diseases Trans-catheter Aortic Valve Implantation Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25

Device

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Al-Ani, MD/PHD candidate

CONTACT

[email protected]

004792831213

Trygve Hall, MD/PHD

CONTACT

[email protected]

004747500700

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.

Acronym: ALIGN-EFX

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 16, 2025
Registry last updated: Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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