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OpenTrials
Completed

NCT Number: NCT03570190

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

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.

Completed

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum München, München, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients not providing written informed consent

Treatment and study plan

Coordinator

Other

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

Primary outcomes

  1. Evaluation of differences in length of stay (LoS)

    Time frame: 12 months

    LoS in days.

  2. Adverse event rate

    Time frame: 30 days

    According to VARC-2 criteria.

  3. Patient satisfaction

    Time frame: 30 days

    Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied).

  4. Economic evaluation

    Time frame: 12 months

    Proportion of early discharges in patients with sAS undergoing TAVI.

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Acronym: Coordinate

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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