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Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05097183
Acronym
ACA
Enrollment
274
Registered
2021-10-28
Start date
2021-12-01
Completion date
2024-12-31
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacement (TAVR)

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).

Interventions

PROCEDUREAccurate 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.

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Gerencia Regional de Salud de Castilla y Leon
CollaboratorOTHER
Ignacio J. Amat Santos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of commissural alignment6 monthsMean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
Successful coronary re-access10 minutes, right after TAVRCoronary re-access was successful or not after TAVR implant
Presence of leaflet thrombosis6 monthsPresence of clinical/subclinical leaflets thrombosis assessed by CT-Scan

Secondary

MeasureTime frameDescription
Residual transvalvular gradients24 monthsResidual transvalvular gradients measured in transthoracic echocardiography

Countries

Spain

Contacts

Primary ContactIgnacio J Amat-Santos, PhD
icicor@icicor.es983420000
Backup ContactCarlos Baladrón, PhD
icicor@icicor.es983420000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026