Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
- Enrollment
- 161
- Locations
- 3
- Primary Endpoint
- Adverse event rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Adverse event rate
Time Frame: 30 days
According to VARC-2 criteria.
Patient satisfaction
Time Frame: 30 days
Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied).
Economic evaluation
Time Frame: 12 months
Proportion of early discharges in patients with sAS undergoing TAVI.
Evaluation of differences in length of stay (LoS)
Time Frame: 12 months
LoS in days.