Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+ (ALIGN-EFX)

University of Oslo (UIO)

Status: Not yet enrolling

Conditions: Aortic Stenosis; Trans-catheter Aortic Valve Implantation; Commissural Alignment

Treatments: Device: Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25; Device: Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.

Study type: Interventional

Funder types: Other

Identifiers

NCT07217691

904586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

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

Active Comparator group

Description:

LAO 25

Treatment:

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 group

Description:

Patient specific degree

Treatment:

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