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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Other: Coordinator

• Registration Number: NCT03570190
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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 Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-06-26
• Study Start: 2018-12-20
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI

Exclusion Criteria

• patients not providing written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVI patients	Coordinator	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

Primary Outcome Measures

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

Trial Locations

Locations (3)

Deutsches Herzzentrum München; 🇩🇪 München, Bayern, Germany

Herz- u. Gefässzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Niedersachsen, Germany

Herz- und Gefäßzentrum; 🇩🇪 Düsseldorf, NRW, Germany