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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Gerencia Regional de Salud de Castilla y Leon | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Transcatheter aortic valve replacement (TAVR) with standard procedure | ||
| ACA | Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accurate Commissural Alignment (ACA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of commissural alignment | Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan | 6 months |
| Successful coronary re-access | Coronary re-access was successful or not after TAVR implant | 10 minutes, right after TAVR |
| Presence of leaflet thrombosis | Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Residual transvalvular gradients | Residual transvalvular gradients measured in transthoracic echocardiography | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio J Amat-Santos, PhD | Contact | 983420000 | 86571 | icicor@icicor.es |
| Carlos Baladrón, PhD | Contact | 983420000 | 86571 | icicor@icicor.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario A Coruña | Recruiting | A Coruña | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33781722 | Background | 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. | |
| 34600863 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Hospital Clinic, Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Spain |
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| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | Spain |
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| Hospital Universitari Bellvitge | Recruiting | L'Hospitalet de Llobregat | Spain |
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| Hospital clínico San Carlos | Recruiting | Madrid | Spain |
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| Hospital La Paz | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
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| Hospital Universitario Virgen de la Victoria | Not yet recruiting | Málaga | Spain |
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| Hospital Clínico Universitario Virgen de la Arrixaca | Recruiting | Murcia | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Spain |
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| Hospital Clínico Universitario de Salamanca | Recruiting | Salamanca | Spain |
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| Hospital Clínico Universitario de Santiago | Recruiting | Santiago de Compostela | Spain |
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| Hospital Virgen del Rocío | Not yet recruiting | Seville | Spain |
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| Hospital Universitario Miguel Servet | Not yet recruiting | Zaragoza | Spain |
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| Background |
| 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. |
| 39252591 | Derived | 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. |
| D014694 |
| Ventricular Outflow Obstruction |