Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05552352

VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease

Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-08-28

300

Participants Needed

2

Research Sites

229 weeks

Total Duration

On this page

Sponsors

H

Heinrich-Heine University, Duesseldorf

Lead Sponsor

E

Edwards Lifesciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.

CONDITIONS

Official Title

VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • High-grade aortic valve stenosis
  • Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
  • Existing heart center decision for treatment
  • Age 18 years or older
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Planned surgery under general anesthesia
  • Insufficient language proficiency to understand the study and VR application
  • Severe hearing impairment preventing understanding of VR sounds
  • Severe visual impairment preventing viewing of VR modules without correction
  • Moderately severe or severe dementia syndrome
  • Known epilepsy or seizure disorder
  • Positive pregnancy test or current pregnancy
  • Court ordered institutional placement
  • Psychosocial conditions likely to prevent protocol compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

2

Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62

Cologne, Germany, 50937

Actively Recruiting

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Research Team

C

Christian Jung, Prof MD PhD

CONTACT

R

Raphael Bruno, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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