Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
NCT ID: NCT03570190
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
161 participants
OBSERVATIONAL
2018-12-20
2019-12-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TAVI patients
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
Coordinator
A THV coordinator will be responsible for communication with the patients and the caregivers as well as for monitoring medical documentation and treatment pathways. The registry will consist of 3 phases:
* Determination of the status quo
* Dedicated reflection and training followed by implementation of tailored changes
* Determination of the effect
Interventions
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Coordinator
A THV coordinator will be responsible for communication with the patients and the caregivers as well as for monitoring medical documentation and treatment pathways. The registry will consist of 3 phases:
* Determination of the status quo
* Dedicated reflection and training followed by implementation of tailored changes
* Determination of the effect
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Katja Bohmann, MD
Role: PRINCIPAL_INVESTIGATOR
Herz- u. Gefässzentrum Bad Bevensen
Locations
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Deutsches Herzzentrum München
München, Bavaria, Germany
Herz- u. Gefässzentrum Bad Bevensen
Bad Bevensen, Lower Saxony, Germany
Herz- und Gefäßzentrum
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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References
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Bohmann K, Burgdorf C, Zeus T, Joner M, Alvarez H, Berning KL, Schikowski M, Kasel AM, van Mark G, Deutsch C, Kurucova J, Thoenes M, Frank D, Wundram S, Bramlage P, Miller B, Veulemans V. The COORDINATE Pilot Study: Impact of a Transcatheter Aortic Valve Coordinator Program on Hospital and Patient Outcomes. J Clin Med. 2022 Feb 23;11(5):1205. doi: 10.3390/jcm11051205.
Other Identifiers
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Coordinate
Identifier Type: -
Identifier Source: org_study_id
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