Clinical trial NCT05097183: Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
Official title: Clinical Validation and Prognostic Evaluation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Aortic Valve Stenosis
Keywords: Transcatheter aortic valve replacement (TAVR)
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Gerencia Regional de Salud de Castilla y Leon
First posted: 2021-10-28
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team and fulfilling inclusion criteria in 16 centers in Spain. The Sponsor is proctoring the new ACA technique in this centers. TAVR patients treated both with standard and ACA technique will be included in the registry.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Degree of commissural alignment
timeFrame: 6 months
measure: Successful coronary re-access
timeFrame: 10 minutes, right after TAVR
measure: Presence of leaflet thrombosis
timeFrame: 6 months
Secondary outcomes:
measure: Residual transvalvular gradients
timeFrame: 24 months
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Clinic, Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari Bellvitge
city: Madrid
country: Spain
facility: Hospital clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
citation: Redondo A, Valencia-Serrano F, Santos-Martinez S, Delgado-Arana JR, Barrero A, Serrador A, Gutierrez H, Sanchez-Lite I, Sevilla T, Revilla A, Baladron C, Kim WK, Carrasco-Moraleja M, San Roman 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.
citation: Redondo A, Santos-Martinez S, Delgado-Arana R, Baladron Zorita C, San Roman 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. No abstract available. English, Spanish.