Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
- Conditions
- Severe Aortic Valve Stenosis
- Interventions
- Procedure: Accurate Commissural Alignment (ACA)
- Registration Number
- NCT05097183
- Lead Sponsor
- Ignacio J. Amat Santos
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 274
- Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team
- Pre-procedure CT-Scan for planning available.
- Signed informed consent.
- Allergic to contrast
- Severe renal failure (GFR < 30 mL/min)
- Indication for chronic anticoagulation
- Horizontal aorta and/or severe aortic tortuosity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ACA Accurate Commissural Alignment (ACA) Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique
- Primary Outcome Measures
Name Time Method Degree of commissural alignment 6 months Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
Successful coronary re-access 10 minutes, right after TAVR Coronary re-access was successful or not after TAVR implant
Presence of leaflet thrombosis 6 months Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan
- Secondary Outcome Measures
Name Time Method Residual transvalvular gradients 24 months Residual transvalvular gradients measured in transthoracic echocardiography
Trial Locations
- Locations (15)
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, 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 La Paz
🇪🇸Madrid, Spain
Hospital Universitari Bellvitge
🇪🇸L'Hospitalet De Llobregat, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain