Transcatheter Aortic Valve Implantation (TAVI)BENCHMARKNCT04579445
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
An observational study of Transcatheter Aortic Valve Implantation (TAVI), run by Institut für Pharmakologie und Präventive Medizin at 28 sites in 7 countries.
Trial summary
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource… Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Transcatheter Aortic Valve Implantation (TAVI)
- What is being tested?
- Education on tailored Quality Improvement measures
- How many people
- 2,408 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 3 May 2021to 1 Aug 2024
- How long will I take part?
- 12 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 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective phase: 50 severe Aortic stenosis patients undergoing transcatheter aortic valve implantation will be recruited within the prospective part per center. Retrospective phase: Retrospective documentation of 30 severe aortic stenosis pateints per center, who underwent a transcatheter aortic valve implantation will be performed.
Who may be able to join
- Retrospective phase:
- Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter aortic valve implantation with a balloon-expandable transcatheter aortic valve prior to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior to the first education call)).
- Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12 Months follow-up: hospital visit or phone call)
- All patients irrespective of valve type or access route will be documented in an electronic Case Report Form (eCRF) based patient logbook.
- Prospective phase:
- Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted for TAVI with a balloon-expandable transcatheter heart valve after center education on BENCHMARK Quality of Care measures and after the center has passed the implementation phase.
- All patients irrespective of valve type or access route will be documented in an eCRF based patient logbook.
Who cannot join
- Retrospective phase:
- Patients with largely incomplete data with respect to the aims of the project.
- Patients without signed informed consent / data protection statement (according to requirements of local ethical committee).
- Pregnant women at the time of the TAVI.
- Prospective phase:
- Patients without signed informed consent prior to the TAVI procedure (data protection statement included; ideally covered by hospital routine to enable consecutiveness).
- Pregnant women at the time of the TAVI.
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
France9 sites
Centre Hospitalier Universitaire de Besancon
Besançon, 25030
Polyclinique Du Bois
Lille, 59000
Infirmerie Protestante de Lyon
Lyon, 69641
Hopital Saint Joseph
Marseille, 13008
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
IMM (Institut Mutualiste Montsouris) Paris
Paris, 74014
Pitie Salpetriere Hospital Paris
Paris, 75013
CHU Rennes
Rennes, 35000
CHRU Tours
Tours, 37000
Germany6 sites
Herzzentrum Köln
Cologne, 50670
University Medical Center Göttingen
Göttingen, 37075
University Hospital Heidelberg
Heidelberg, 69120
Saarland University Medical Center
Homburg, 66421
CKMS Munich, Artemed Clinics
Munich, 81379
Brüderkrankenhaus Trier
Trier, 54292
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Bellvitge
Barcelona, 08905
Hospital Clinico San Carlos
Madrid, 28040
Hospital Regional Universitario de Málaga
Málaga, 29001
Hospital Universitari Son Espases
Palma de Mallorca, 07020
Italy4 sites
L'Ospedale S.Giuseppe Moscati di Avellino
Avellino, 83100
Careggi Hospital
Florence, 50134
Centro Cardiologico, Monzino Hospital
Milan, 20141
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Austria2 sites
St. Pölten University Hospital
Sankt Pölten, 3100
KH Nord, Klinik Floridsdorf
Vienna, 1210
Romania1 site
Institutul de Urgenta pentru Boli Cardiolvasculaire
Bucharest, 022322
About this study
Official title: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
The registry will consist of the following phases:
- Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months).
- Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures).
- Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months.
- Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)
Read the detailed description
Transcatheter aortic valve implantation (TAVI) has become standard of care in patients suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite the advances in valve technology and implantation techniques, there is still no consensus on how to effectively screen, manage and discharge patients undergoing such an intervention.
In an effort not to lose grounds because of an increasing inner-hospital competition for resources including intensive care unit (ICU) and general hospital beds, there is a need for a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but with at least the same patient safety. In this context, the recent FAST-TAVI (Feasibility And Safety of early discharge after Transfemoral TAVI) and North American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that optimized risk assessment and patient management results in a more effective, as least as safe treatment pathway and a reduced length of stay (LoS).
The results gain importance especially in a situation where patients suffering from the coronavirus disease compete for hospital resources throughout Europe. Using a clear set of Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be made if tailored Quality of Care improvement measures are initiated.
The hypothesis is that the implementation of standardized, reproducible and scalable Quality of Care improvement measures will help reducing resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France, Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400 patients in total.
- Being tested
- Education on tailored Quality Improvement measures
- Keywords
- TAVI, Severe Aortic Stenosis, Optimizing TAVI patient outcomes, Optimizing TAVI care pathways
- 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.
Education on tailored Quality Improvement measuresOther
Also called Education on Quality of Care Improvement measures
Centers will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety.
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients | Consecutive, severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) (there will be a retrospective part: documentation of 30 patients who underwent transfemoral TAVI; and a prospective part enrolling 50 patients undergoing transfemoral TAVI) Receives: Other: Education on tailored Quality Improvement measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of differences in length of stay (LoS)
LoS in days
Measured: 12 months
Complication rate (AEs), TAVI related safety outcomes
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Measured: 30 days
Complication rate (AEs), TAVI related safety outcomes
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Measured: 12 months
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Measured: 30 days
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Measured: 12 months
Resource utilization - Early discharge information
To determine the proportion of early discharges in sAS patients undergoing TAVI
Measured: 12 months
Resource utilization - Working hours per patient
To determine the working hours per patient
Measured: 12 months
Resource utilization - Number of TAVI patients in each center
To determine the number of patients undergoing TAVI (per center)
Measured: 12 months
Physician and patient satisfaction
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Measured: 30 days
Physician and patient satisfaction
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start3 May 2021
- Primary completion30 Apr 2023
- Study completion1 Aug 2024
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 Transcatheter Aortic Valve Implantation (TAVI)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,408 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Derk Frank, Prof., Principal investigator, UKSH KielGemma McCalmont, Principal investigator, James Cook Hospital, Middlesbrough, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579445
- Sponsor's protocol ID
- BENCHMARK Registry
- Acronym
- BENCHMARK
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data (IPD) will be shared
Publications
McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Luske CM, Kurucova J, Bramlage P, Frank D. Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9.
PubMed 34499383Frank D, Durand E, Lauck S, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Saia F, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Saint Etienne C, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, Hachaturyan V, Luske CM, Rakova R, Wesselink W, Kurucova J, Bramlage P, McCalmont G; BENCHMARK Investigator Group. A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study. Eur Heart J. 2024 Jun 1;45(21):1904-1916. doi: 10.1093/eurheartj/ehae147.
PubMed 38554125Saia F, Lauck S, Durand E, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Etienne CS, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, McCalmont G, Rakova R, Wesselink W, Kurucova J, Hachaturyan V, Luske CM, Bramlage P, Frank D; BENCHMARK Investigator Group. The implementation of a streamlined TAVI patient pathway across five European countries: BENCHMARK registry. Clin Res Cardiol. 2026 Jul;115(7):1107-1119. doi: 10.1007/s00392-025-02638-z. Epub 2025 Apr 22.
PubMed 40261426
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
- ClinicalTrials.gov ID
- NCT04579445
- Acronym / sponsor ID
- BENCHMARK / BENCHMARK Registry
- Keywords
- TAVI, Severe Aortic Stenosis, Optimizing TAVI patient outcomes, Optimizing TAVI care pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,408 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Oct 2020 (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.
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
The registry will consist of the following phases:
- Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months).
- Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures).
- Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months.
- Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)
Detailed description
Transcatheter aortic valve implantation (TAVI) has become standard of care in patients suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite the advances in valve technology and implantation techniques, there is still no consensus on how to effectively screen, manage and discharge patients undergoing such an intervention.
In an effort not to lose grounds because of an increasing inner-hospital competition for resources including intensive care unit (ICU) and general hospital beds, there is a need for a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but with at least the same patient safety. In this context, the recent FAST-TAVI (Feasibility And Safety of early discharge after Transfemoral TAVI) and North American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that optimized risk assessment and patient management results in a more effective, as least as safe treatment pathway and a reduced length of stay (LoS).
The results gain importance especially in a situation where patients suffering from the coronavirus disease compete for hospital resources throughout Europe. Using a clear set of Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be made if tailored Quality of Care improvement measures are initiated.
The hypothesis is that the implementation of standardized, reproducible and scalable Quality of Care improvement measures will help reducing resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France, Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400 patients in total.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | Other: Education on tailored Quality Improvement measuresConsecutive, severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) (there will be a retrospective part: documentation of 30 patients who underwent transfemoral TAVI; and a prospective part enrolling 50 patients undergoing transfemoral TAVI) |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective phase: 50 severe Aortic stenosis patients undergoing transcatheter aortic valve implantation will be recruited within the prospective part per center. Retrospective phase: Retrospective documentation of 30 severe aortic stenosis pateints per center, who underwent a transcatheter aortic valve implantation will be performed.
Key inclusion criteria (7 listed)
- Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter aortic valve implantation with a balloon-expandable transcatheter aortic valve prior to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior to the first education call)).
- Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12 Months follow-up: hospital visit or phone call)
- All patients irrespective of valve type or access route will be documented in an electronic Case Report Form (eCRF) based patient logbook.
- Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted for TAVI with a balloon-expandable transcatheter heart valve after center education on BENCHMARK Quality of Care measures and after the center has passed the implementation phase.
- All patients irrespective of valve type or access route will be documented in an eCRF based patient logbook.
Key exclusion criteria (7 listed)
- Patients with largely incomplete data with respect to the aims of the project.
- Patients without signed informed consent / data protection statement (according to requirements of local ethical committee).
- Pregnant women at the time of the TAVI.
- Patients without signed informed consent prior to the TAVI procedure (data protection statement included; ideally covered by hospital routine to enable consecutiveness).
- Pregnant women at the time of the TAVI.
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 |
|---|---|---|
| Education on tailored Quality Improvement measuresAlso: Education on Quality of Care Improvement measuresCenters will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety. | Other | TAVI patients |
Primary outcome
Evaluation of differences in length of stay (LoS)
Time frame: 12 months
LoS in days
Complication rate (AEs), TAVI related safety outcomes
Time frame: 30 days
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Complication rate (AEs), TAVI related safety outcomes
Time frame: 12 months
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Time frame: 30 days
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Time frame: 12 months
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Resource utilization - Early discharge information
Time frame: 12 months
To determine the proportion of early discharges in sAS patients undergoing TAVI
Resource utilization - Working hours per patient
Time frame: 12 months
To determine the working hours per patient
Resource utilization - Number of TAVI patients in each center
Time frame: 12 months
To determine the number of patients undergoing TAVI (per center)
Physician and patient satisfaction
Time frame: 30 days
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Physician and patient satisfaction
Time frame: 12 months
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 34499383McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Luske CM, Kurucova J, Bramlage P, Frank D. Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9.
- Results publication: PubMed 38554125Frank D, Durand E, Lauck S, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Saia F, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Saint Etienne C, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, Hachaturyan V, Luske CM, Rakova R, Wesselink W, Kurucova J, Bramlage P, McCalmont G; BENCHMARK Investigator Group. A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study. Eur Heart J. 2024 Jun 1;45(21):1904-1916. doi: 10.1093/eurheartj/ehae147.
- Derived from this study: PubMed 40261426Saia F, Lauck S, Durand E, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Etienne CS, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, McCalmont G, Rakova R, Wesselink W, Kurucova J, Hachaturyan V, Luske CM, Bramlage P, Frank D; BENCHMARK Investigator Group. The implementation of a streamlined TAVI patient pathway across five European countries: BENCHMARK registry. Clin Res Cardiol. 2026 Jul;115(7):1107-1119. doi: 10.1007/s00392-025-02638-z. Epub 2025 Apr 22.
- Registry webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. no individual participant data (IPD) will be shared
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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.
Derk Frank, Prof. principal investigator
UKSH Kiel
Gemma McCalmont principal investigator
James Cook Hospital, Middlesbrough, United Kingdom
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation (TAVI), run by Institut für Pharmakologie und Präventive Medizin at 28 sites in 7 countries.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Germany, Spain, Italy, Austria and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of differences in length of stay (LoS) (time frame: 12 months). The study lists 10 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 NCT04579445, 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 1 Oct 2024.