Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation (ACA)

Ignacio J. Amat Santos

Status: Enrolling

Conditions: Severe Aortic Valve Stenosis

Treatments: Procedure: Accurate Commissural Alignment (ACA)

Study type: Observational

Funder types: Other

Identifiers

NCT05097183

ICICOR-ACA-2021

Details and patient eligibility

About

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).

Enrollment: 274 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

274 participants in 2 patient groups

Control

Description:

Transcatheter aortic valve replacement (TAVR) with standard procedure

ACA

Description:

Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique

Treatment:

Procedure: Accurate Commissural Alignment (ACA)