Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Coordinator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI Exclusion Criteria: patients not providing written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI patients<br>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 | Other: Coordinator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of differences in length of stay (LoS) | LoS in days. | 12 months | 
| Adverse event rate | According to VARC-2 criteria. | 30 days | 
| Patient satisfaction | Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied). | 30 days | 
| Economic evaluation | Proportion of early discharges in patients with sAS undergoing TAVI. | 12 months |