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

NCT03570190 | Completed

• 1 other identifier: Coordinate
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

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

TAVI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• patients not providing written informed consent

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (3)

Deutsches Herzzentrum München

München, Bavaria, 80636, Germany

Location

Herz- u. Gefässzentrum Bad Bevensen

Bad Bevensen, Lower Saxony, 29549, Germany

Location

Herz- und Gefäßzentrum

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

• 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.

  PMID: 35268296 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Katja Bohmann, MD

  Herz- u. Gefässzentrum Bad Bevensen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: June 26, 2018
• Study Start: December 20, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)