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

NCT07217691 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-16

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Trans-catheter Aortic Valve Implantation
  • Commissural Alignment

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-05-01
Completion
2026-05-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217691 on ClinicalTrials.gov