Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation (ACA)

April 13, 2022 updated by: Ignacio J. Amat Santos

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio J Amat-Santos, PhD
  • Phone Number: 86571 983420000
  • Email: icicor@icicor.es

Study Contact Backup

  • Name: Carlos Baladrón, PhD
  • Phone Number: 86571 983420000
  • Email: icicor@icicor.es

Study Locations

  • Spain
      • A Coruña, Spain
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
          • Pablo Piñón
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Álvaro Calabuig
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic, Barcelona
      • Córdoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Manuel P Álvarez Ossorio
      • L'Hospitalet De Llobregat, Spain
        • Recruiting
        • Hospital Universitari Bellvitge
        • Contact:
          • Joan A Gómez Hospital
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Not yet recruiting
        • Hospital La Paz
      • Murcia, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
          • Eduardo Pinar
      • Málaga, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Antonio J. Muñoz
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Raquel del Valle
      • Salamanca, Spain
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
      • Santiago De Compostela, Spain
        • Recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
          • Ramiro Trillo
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Virgen del Rocío
        • Contact:
          • José F Díaz
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • José A Diarte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Transcatheter aortic valve replacement (TAVR) with standard procedure
ACA
Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of commissural alignment
Time Frame: 6 months
Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
6 months
Successful coronary re-access
Time Frame: 10 minutes, right after TAVR
Coronary re-access was successful or not after TAVR implant
10 minutes, right after TAVR
Presence of leaflet thrombosis
Time Frame: 6 months
Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual transvalvular gradients
Time Frame: 24 months
Residual transvalvular gradients measured in transthoracic echocardiography
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ignacio J. Amat Santos

Collaborators

Instituto de Salud Carlos III
Gerencia Regional de Salud de Castilla y Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (ACTUAL)

October 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICICOR-ACA-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Aortic Valve Stenosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe