NCT05097183

Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 274 (estimated)
• Sponsor: Ignacio J. Amat Santos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Severe Aortic Valve Stenosis

Interventions

Type	Name	Description
PROCEDURE	Accurate Commissural Alignment (ACA)	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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-10-28
• Last updated: 2022-04-20

Locations

15 sites across 1 country: Spain