Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of differences in length of stay (LoS) | LoS in days. | 12 months |
| Adverse event rate | According to VARC-2 criteria. | 30 days |
| Patient satisfaction | Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied). | 30 days |
| Economic evaluation | Proportion of early discharges in patients with sAS undergoing TAVI. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katja Bohmann, MD | Herz- u. Gefässzentrum Bad Bevensen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | München | Bavaria | 80636 | Germany | ||
| Herz- u. Gefässzentrum Bad Bevensen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35268296 | Result | 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 Coordinator Program on Hospital and Patient Outcomes. J Clin Med. 2022 Feb 23;11(5):1205. doi: 10.3390/jcm11051205. |
Not provided
Not provided
no IPD will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bad Bevensen |
| Lower Saxony |
| 29549 |
| Germany |
| Herz- und Gefäßzentrum | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| D014694 |
| Ventricular Outflow Obstruction |