Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis degeneration that could require TAVR-in-TAVR for its treatment progressively increases. During standard TAVI procedures the native and the prosthesis commissures are randomly aligned with misalignment in up to 70% of the cases. This might hinder coronary re-access in 18% of the cases, increase the risk of coronary obstruction during future TAVR-in-TAVR procedures, and has been associated to greater residual gradients. Methods: Although several techniques have been developed to increase the degree of commissural alignment, all are imperfect or imply manipulation of the system within the patient, potentially increasing the risk of complications. The research team developed a software based on computed tomography analysis that allows planification of accurate commissural alignment by inserting the delivery system in a patient-specific degree of rotation. Aim: The proponent team aimed to prospectively validate this methodology comparing a cohort of patients harboring TAVR with Acurate Commissural Alignment (ACA) vs. a control cohort with non-ACA standard technique, in order to determine benefits in terms of coronary re-access and clinical events (coronary events, valve degeneration, and TAVR-in-TAVR).

Official Title
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Clinical Validation and Prognostic Evaluation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

Conditions
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Severe Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Accurate Commissural Alignment (ACA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team Pre-procedure CT-Scan for planning available. Signed informed consent. Exclusion Criteria: Allergic to contrast Severe renal failure (GFR < 30 mL/min) Indication for chronic anticoagulation Horizontal aorta and/or severe aortic tortuosity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Transcatheter aortic valve replacement (TAVR) with standard procedure | |
| ACA<br>Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique | Procedure: Accurate Commissural Alignment (ACA)<br>* Software based, computed tomography analysis that allows planification of accurate commissural alignment of TAVR by inserting the delivery system in a patient-specific degree of rotation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of commissural alignment | Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan | 6 months | 
| Successful coronary re-access | Coronary re-access was successful or not after TAVR implant | 10 minutes, right after TAVR | 
| Presence of leaflet thrombosis | Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual transvalvular gradients | Residual transvalvular gradients measured in transthoracic echocardiography | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve replacement (TAVR)