Aortic Valve StenosisCoordinateNCT03570190
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 3 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Coordinator
- How many people
- 161 participants
- Where
- 3 sitesGermany
- Study dates
- 20 Dec 2018to 19 Dec 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI
Who cannot join
- patients not providing written informed consent
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Herz- u. Gefässzentrum Bad Bevensen
Bad Bevensen, Lower Saxony, 29549
Herz- und Gefäßzentrum
Düsseldorf, North Rhine-Westphalia, 40225
Deutsches Herzzentrum München
München, Bavaria, 80636
About this study
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):
Read more
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Coordinator
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoordinatorOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Coordinator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of differences in length of stay (LoS)
LoS in days.
Measured: 12 months
Adverse event rate
According to VARC-2 criteria.
Measured: 30 days
Patient satisfaction
Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied).
Measured: 30 days
Economic evaluation
Proportion of early discharges in patients with sAS undergoing TAVI.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start20 Dec 2018
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Katja Bohmann, MD, Principal investigator, Herz- u. Gefässzentrum Bad Bevensen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570190
- Sponsor's protocol ID
- Coordinate
- Acronym
- Coordinate
- Status last verified
- May 2022
- First submitted
- 23 Mar 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared
Publications
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.
PubMed 35268296
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
- ClinicalTrials.gov ID
- NCT03570190
- Acronym / sponsor ID
- Coordinate / Coordinate
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | Other: Coordinatorelective 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI
Key exclusion criteria (1 listed)
- patients not providing written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoordinatorA 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 | Other | TAVI patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 35268296Bohmann 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.
- Individual participant dataSharing planned: No. no IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Bohmann, MD principal investigator
Herz- u. Gefässzentrum Bad Bevensen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of differences in length of stay (LoS) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.