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
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|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||161 participants|
|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|
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
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:
- Evaluation of differences in length of stay (LoS) [ Time Frame: 12 months ]LoS in days.
- 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.
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
|Deutsches Herzzentrum München|
|München, Bayern, Germany, 80636|
|Herz- u. Gefässzentrum Bad Bevensen|
|Bad Bevensen, Niedersachsen, Germany, 29549|
|Herz- und Gefäßzentrum|
|Düsseldorf, NRW, Germany, 40225|
|Principal Investigator:||Katja Bohmann, MD||Herz- u. Gefässzentrum Bad Bevensen|