Severe Aortic Valve StenosisACANCT05097183
Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
An observational study of Severe Aortic Valve Stenosis, run by Ignacio J. Amat Santos at 15 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- Accurate Commissural Alignment (ACA)
- Type of treatment
- Surgery or procedure
- How many people
- 274 participants
- Where
- 15 sitesSpain
- Study dates
- 1 Dec 2021to 31 Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team
- Pre-procedure CT-Scan for planning available.
- Signed informed consent.
Who cannot join
- Allergic to contrast
- Severe renal failure (GFR < 30 mL/min)
- Indication for chronic anticoagulation
- Horizontal aorta and/or severe aortic tortuosity
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites, 15 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña
Pablo Piñón
- Recruiting
Hospital Clinic, Barcelona
Barcelona
Ander Regueiro
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Álvaro Calabuig
- Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba
Manuel P Álvarez Ossorio
- Recruiting
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat
Joan A Gómez Hospital
- Recruiting
Hospital clínico San Carlos
Madrid
Luis Nombela
- Not yet recruiting
Hospital La Paz
Madrid
Raúl Moreno
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Ángel Sánchez Recalde
- Not yet recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Antonio J. Muñoz
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Eduardo Pinar
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
Raquel del Valle
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
Ignacio Cruz
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Ramiro Trillo
- Not yet recruiting
Hospital Virgen del Rocío
Seville
José F Díaz
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza
José A Diarte
About this study
Official title: 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).
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- Accurate Commissural Alignment (ACA)
- Keywords
- Transcatheter aortic valve replacement (TAVR)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accurate Commissural Alignment (ACA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Transcatheter aortic valve replacement (TAVR) with standard procedure | |
| ACA | Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique Receives: Procedure: Accurate Commissural Alignment (ACA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of commissural alignment
Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
Measured: 6 months
Successful coronary re-access
Coronary re-access was successful or not after TAVR implant
Measured: 10 minutes, right after TAVR
Presence of leaflet thrombosis
Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan
Measured: 6 months
Secondary outcomes (1)
Residual transvalvular gradients
Residual transvalvular gradients measured in transthoracic echocardiography
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Ignacio J. Amat Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Gerencia Regional de Salud de Castilla y Leon
- Responsible party
- Sponsor-investigator, Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097183
- Sponsor's protocol ID
- ICICOR-ACA-2021
- Acronym
- ACA
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33781722Redondo 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.
PubMed 34600863Amat-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.
PubMed 39252591
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation and Prognostic Evaluation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05097183
- Acronym / sponsor ID
- ACA / ICICOR-ACA-2021
- Conditions
- Severe Aortic Valve Stenosis
- Keywords
- Transcatheter aortic valve replacement (TAVR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Ignacio J. Amat SantosUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Gerencia Regional de Salud de Castilla y Leon
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Transcatheter aortic valve replacement (TAVR) with standard procedure |
| ACA | – | Procedure: Accurate Commissural Alignment (ACA)Transcatheter aortic valve replacement (TAVR) with Accurate Commissural Alignment (ACA) technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients diagnosed with severe aortic stenosis admitted to TAVR by Heart Team
- Pre-procedure CT-Scan for planning available.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Allergic to contrast
- Severe renal failure (GFR < 30 mL/min)
- Indication for chronic anticoagulation
- Horizontal aorta and/or severe aortic tortuosity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | ACA |
Primary outcome
Degree of commissural alignment
Time frame: 6 months
Mean minimum angular deviation between TAVR posts and aortic valve commissures measured in CT-scan
Successful coronary re-access
Time frame: 10 minutes, right after TAVR
Coronary re-access was successful or not after TAVR implant
Presence of leaflet thrombosis
Time frame: 6 months
Presence of clinical/subclinical leaflets thrombosis assessed by CT-Scan
1 secondary outcome
Residual transvalvular gradients
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 33781722Redondo 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.
- Background: PubMed 34600863Redondo 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.
- Derived from this study: PubMed 39252591Amat-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Valve Stenosis, run by Ignacio J. Amat Santos at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio J Amat-Santos, PhD (983420000 ext. 86571, icicor@icicor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of commissural alignment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097183, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.