MedTrace Logo

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

NCT03570190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 161

Last updated 2022-05-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Katja Bohmann, MD · Herz- u. Gefässzentrum Bad Bevensen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570190 on ClinicalTrials.gov