Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
NCT ID: NCT05097183
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
274 participants
OBSERVATIONAL
2021-12-01
2024-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control
Transcatheter aortic valve replacement (TAVR) with standard procedure
No interventions assigned to this group
ACA
Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pre-procedure CT-Scan for planning available.
* Signed informed consent.
Exclusion Criteria
* Severe renal failure (GFR \< 30 mL/min)
* Indication for chronic anticoagulation
* Horizontal aorta and/or severe aortic tortuosity
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Gerencia Regional de Salud de Castilla y Leon
OTHER
Ignacio J. Amat Santos
OTHER
Responsible Party
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Ignacio J. Amat Santos
Coordinator of Interventional Cardiology Unit
Locations
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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
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Pablo Piñón
Role: primary
Ander Regueiro
Role: primary
Álvaro Calabuig
Role: primary
Manuel P Álvarez Ossorio
Role: primary
Joan A Gómez Hospital
Role: primary
Luis Nombela
Role: primary
Raúl Moreno
Role: primary
Ángel Sánchez Recalde
Role: primary
Antonio J. Muñoz
Role: primary
Eduardo Pinar
Role: primary
Raquel del Valle
Role: primary
Ignacio Cruz
Role: primary
Ramiro Trillo
Role: primary
José F Díaz
Role: primary
José A Diarte
Role: primary
References
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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.
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.
Amat-Santos IJ, Gomez-Herrero J, Pinon P, Nombela-Franco L, Moreno R, Munoz-Garcia AJ, Redondo A, Gomez-Menchero A, Gomez-Salvador I, San Roman JA. Impact of commissural alignment on the hemodynamic performance of supra-annular self-expandable transcatheter aortic valves. Catheter Cardiovasc Interv. 2024 Nov;104(5):1060-1070. doi: 10.1002/ccd.31201. Epub 2024 Sep 10.
Other Identifiers
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ICICOR-ACA-2021
Identifier Type: -
Identifier Source: org_study_id
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