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Recruiting

NCT Number: NCT06706635

Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis

The aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location status: Recruiting

Location contact

Astrid Kleemeyer

CONTACT

[email protected]

+49 5731 971258

Sara Waezsada, MD

CONTACT

Tanja K. Rudolph, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe aortic valve stenosis
  • planned aortic valve replacement (TAVI)
  • Patient is willing and able to complete the surveys in German language
  • Written informed consent by the trial subject

Exclusion criteria

  • Language barrier

Treatment and study plan

Application of App

Device

Full Access to Mobile App

Primary outcomes

  1. Subjective information level (EORTC QOL-INFO 25 questionnaire)

    Time frame: From enrollment to the end of FU at 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Kleemeyer

CONTACT

[email protected]

49 5731 971258

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

Impact of Enhanced Information Provision by Using a Mobile App on Subjective Information Level As the Basis for Shared-decision Making and Patient-reported Outcome Measures (PROMs) in Patients with Aortic Stenosis

Acronym: TAVI-SDM-APP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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