Brief Title
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Official Title
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Brief Summary
Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months): Documentation of treatment pathways and endpoints of "routine" patients without educational program Dedicated reflection and training (1 day): One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements. Implementation of tailored changes (2 months): Implementation of the changes developed in the training. Determination of the effect (3 months): Coordinator measures optimization changes and determines effects.
Detailed Description
Along the severe aortic stenosis (sAS) treatment pathway there are delays that may impact quality management and hospital efficiency. A dedicated valve coordinator, interfering with all stages of patient handling throughout the hospital may increase the efficiency of the sAS patient flow, accelerate decision making and clinical outcomes while at the same time decreasing resource consumption. The hypothesis is that the implementation of a dedicated valve coordinator will improve the patient flow of sAS patients scheduled to undergo TAVI, their outcome, patient and physician satisfaction and will optimize costs. In total, three centers across Germany (Munich, Düsseldorf, Bad Bevensen) will participate.
Study Type
Observational [Patient Registry]
Primary Outcome
Evaluation of differences in length of stay (LoS)
Condition
Aortic Valve Stenosis
Intervention
Coordinator
Study Arms / Comparison Groups
TAVI patients
Description: elective patients with a diagnosis of sAS and admitted for TAVI attending one of the participating centers for commercially available balloon expandable valve implantation that will be managed by a coordinator
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
161
Start Date
December 20, 2018
Completion Date
December 19, 2019
Primary Completion Date
December 19, 2019
Eligibility Criteria
Inclusion Criteria: - elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI Exclusion Criteria: - patients not providing written informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Katja Bohmann, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03570190
Organization ID
Coordinate
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Edwards Lifesciences
Study Sponsor
Katja Bohmann, MD, Principal Investigator, Herz- u. Gefässzentrum Bad Bevensen
Verification Date
May 2022