NCT05097183

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

October 15, 2021

Last Update Submit

April 13, 2022

Conditions

Severe Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacement (TAVR)

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Residual transvalvular gradients

    24 months

Study Arms (2)

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)

Interventions

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.

ACA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team
  • Pre-procedure CT-Scan for planning available.
  • Signed informed consent.

You may not qualify if:

  • Allergic to contrast
  • Severe renal failure (GFR \< 30 mL/min)
  • Indication for chronic anticoagulation
  • Horizontal aorta and/or severe aortic tortuosity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

RECRUITING

Hospital Clinic, Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

NOT YET RECRUITING

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Spain

RECRUITING

Hospital clínico San Carlos

Madrid, Spain

RECRUITING

Hospital La Paz

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital Virgen del Rocío

Seville, Spain

NOT YET RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 33781722BACKGROUND

  • 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.

    PMID: 34600863BACKGROUND

  • 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.

    PMID: 39252591DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Ignacio J Amat-Santos, PhD

CONTACT

983420000icicor@icicor.es

Carlos Baladrón, PhD

CONTACT

983420000icicor@icicor.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinator of Interventional Cardiology Unit

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 28, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(15)