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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570190
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Aortic Valve Stenosis Other: Coordinator

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 161 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAVI patients
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

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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI attending one of the participating centers for commercially available balloon expandable valve implantation will be recruited.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570190


Locations
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Germany
Deutsches Herzzentrum München
München, Bayern, Germany, 80636
Herz- u. Gefässzentrum Bad Bevensen
Bad Bevensen, Niedersachsen, Germany, 29549
Herz- und Gefäßzentrum
Düsseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Katja Bohmann, MD Herz- u. Gefässzentrum Bad Bevensen

Additional Information:

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03570190    
Other Study ID Numbers: Coordinate
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction