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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04579445




Registration number
NCT04579445
Ethics application status
Date submitted
28/09/2020
Date registered
8/10/2020

Titles & IDs
Public title
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
Scientific title
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
Secondary ID [1] 0 0
BENCHMARK Registry
Universal Trial Number (UTN)
Trial acronym
BENCHMARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transcatheter Aortic Valve Implantation (TAVI) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Education on tailored Quality Improvement measures

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)


Other interventions: Education on tailored Quality 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of differences in length of stay (LoS)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Complication rate (AEs), TAVI related safety outcomes
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Complication rate (AEs), TAVI related safety outcomes
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Timepoint [4] 0 0
30 days
Primary outcome [5] 0 0
Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Resource utilization - Early discharge information
Timepoint [6] 0 0
12 months
Primary outcome [7] 0 0
Resource utilization - Working hours per patient
Timepoint [7] 0 0
12 months
Primary outcome [8] 0 0
Resource utilization - Number of TAVI patients in each center
Timepoint [8] 0 0
12 months
Primary outcome [9] 0 0
Physician and patient satisfaction
Timepoint [9] 0 0
30 days
Primary outcome [10] 0 0
Physician and patient satisfaction
Timepoint [10] 0 0
12 months

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
115 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2024
Sample size
Target
Accrual to date
Final
2408
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
St. Pölten
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
France
State/province [4] 0 0
Besançon
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Rennes
Country [11] 0 0
France
State/province [11] 0 0
Tours
Country [12] 0 0
Germany
State/province [12] 0 0
Cologne
Country [13] 0 0
Germany
State/province [13] 0 0
Göttingen
Country [14] 0 0
Germany
State/province [14] 0 0
Heidelberg
Country [15] 0 0
Germany
State/province [15] 0 0
Homburg
Country [16] 0 0
Germany
State/province [16] 0 0
Munich
Country [17] 0 0
Germany
State/province [17] 0 0
Trier
Country [18] 0 0
Italy
State/province [18] 0 0
Avellino
Country [19] 0 0
Italy
State/province [19] 0 0
Florence
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Italy
State/province [21] 0 0
Torino
Country [22] 0 0
Romania
State/province [22] 0 0
Bucharest
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Málaga
Country [26] 0 0
Spain
State/province [26] 0 0
Palma De Mallorca

Funding & Sponsors
Primary sponsor type
Other
Name
Institut für Pharmakologie und Präventive Medizin
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Edwards Lifesciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Derk Frank, Prof.
Address 0 0
UKSH Kiel
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no individual participant data (IPD) will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Frank D, Durand E, Lauck S, Muir DF, Spence M, Vas... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04579445