Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

Severe Aortic Valve Stenosis Clinical Trial

— ACA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097183
• Other study ID #: ICICOR-ACA-2021
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Hospital Clínico Universitario de Valladolid
• Contact: Ignacio J Amat-Santos, PhD
• Phone: 983420000
• Email: icicor[@]icicor.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Clinic, Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitari Bellvitge	L'Hospitalet De Llobregat
Spain	Hospital clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Ignacio J. Amat Santos	Gerencia Regional de Salud de Castilla y León, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Redondo A, Santos-Martínez S, Delgado-Arana R, Baladrón Zorita C, San Román JA, Amat-Santos IJ. Fluoroscopic-based algorithm for commissural alignment assessment after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2022 Feb;75(2):184-187. doi: 10.1016/j.rec.2021.08.010. Epub 2021 Sep 30. English, Spanish. — View Citation

Redondo A, Valencia-Serrano F, Santos-Martínez S, Delgado-Arana JR, Barrero A, Serrador A, Gutiérrez H, Sánchez-Lite I, Sevilla T, Revilla A, Baladrón C, Kim WK, Carrasco-Moraleja M, San Román JA, Amat-Santos IJ. Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept. Rev Esp Cardiol (Engl Ed). 2022 Mar;75(3):203-212. doi: 10.1016/j.rec.2021.02.004. Epub 2021 Mar 26. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of commissural alignment	Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan	6 months
Primary	Successful coronary re-access	Coronary re-access was successful or not after TAVR implant	10 minutes, right after TAVR
Primary	Presence of leaflet thrombosis	Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan	6 months
Secondary	Residual transvalvular gradients	Residual transvalvular gradients measured in transthoracic echocardiography	24 months