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

Aortic Valve Stenosis Clinical Trial

— Coordinate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570190
• Other study ID #: Coordinate
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: December 19, 2019

Study information

• Verified date: May 2022
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients not providing written informed consent

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Herz- u. Gefässzentrum Bad Bevensen	Bad Bevensen	Niedersachsen
Germany	Herz- und Gefäßzentrum	Düsseldorf	NRW
Germany	Deutsches Herzzentrum München	München	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

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