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

NCT ID: NCT05552352

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2027-02-28

Brief Summary

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.

Detailed Description

This prospective, randomized-controlled multicenter study investigates whether VR-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. Disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. Virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. More detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. As a result, length of stay should be reduced.

Conditions

Severe Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Patients in the intervention arm receive on the day before the implantation of the artificial aortic valve, a virtual reality assisted information. On the day of the implantation the patients are informed about the process via virtual reality assisted information.

Group Type: EXPERIMENTAL

Virtual Reality assisted information

Intervention Type: OTHER

Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.

Control Arm

Patients in the control arm receive no virtual reality assisted information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality assisted information

Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• High-grade aortic valve stenosis
• Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
• Existing heart center decision
• Age ≥ 18 years
• Signed informed consent form

Exclusion Criteria

• Surgery planned under general anesthesia
• Language barrier, defined as insufficient language proficiency at the discretion of the investigator to understand the purpose of the trial and follow the VR application.
• Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the VRAP-Heart software
• Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasses) together with the VR glasses in the event of defective vision, tested with the VR goggles fitted without using the VRAP-Heart software
• Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion
• Known seizure disorder (epilepsy)
• Positive pregnancy test on inclusion and/or pregnancy is present
• Court ordered placement in an institution
• Any psychosocial condition that makes compliance with the protocol unlikely

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Jung, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine University, Duesseldorf

Locations

Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

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

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christian Jung, Prof MD PhD

Role: CONTACT

christian.jung@med.uni-duesseldorf.de

+49 211 81 ext. 18567

Raphael Bruno, MD

Role: CONTACT

raphael.bruno@med.uni-duesseldorf.de

+49 211 81 ext. 18800

Facility Contacts

Christian Jung, Prof. MD PhD

Role: primary

christian.jung@med.uni-duesseldorf.de

+4921181 ext. 18567

Raphael Bruno, MD

Role: backup

raphael.bruno@med.uni-duesseldorf.de

+4921181 ext. 18800

Matti Adam, PD Dr.

Role: primary

matti.adam@uk-koeln.de

+49 221 478-8777

Other Identifiers

VRAP-Heart

Identifier Type: -

Identifier Source: org_study_id