Clinical trial NCT03570190: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2018-06-26
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI attending one of the participating centers for commercially available balloon expandable valve implantation will be recruited.

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.

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

Primary outcomes:
measure: Evaluation of differences in length of stay (LoS)
timeFrame: 12 months
measure: Adverse event rate
timeFrame: 30 days
measure: Patient satisfaction
timeFrame: 30 days
measure: Economic evaluation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum München
state: Bayern
city: Bad Bevensen
country: Germany
facility: Herz- u. Gefässzentrum Bad Bevensen
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Herz- und Gefäßzentrum
state: NRW
Study officials:
affiliation: Herz- u. Gefässzentrum Bad Bevensen
name: Katja Bohmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.