Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25
DeviceIn 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.
DeviceIn this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Standard rotation of delevery system in the descending aorta at LAO 25 degreeActive comparator 1 intervention
Group B: Rotation of delivery system in the descending aorta with patient-specific degree obtained from CTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Achievement commissural alignment.
Proportion of patients achieving commissural alignment post-TAVI (measured by CT-analysis after TAVI).
Time frame
Day 1 (post-procedure CT).2
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.
Time frame
Day 1 (post-procedure CT)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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