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

VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Valve Stenosis
• Intervention / Treatment: Other: Virtual Reality assisted information

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Jung, Prof MD PhD; Phone Number: 18567 +49 211 81; Email: christian.jung@med.uni-duesseldorf.de
• Study Contact Backup: Name: Raphael Bruno, MD; Phone Number: 18800 +49 211 81; Email: raphael.bruno@med.uni-duesseldorf.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62
    • Contact: Matti Adam, PD Dr.; Phone Number: +49 221 478-8777; Email: matti.adam@uk-koeln.de
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Recruiting
      • Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie
      • Contact: Christian Jung, Prof. MD PhD; Phone Number: 18567 +4921181; Email: christian.jung@med.uni-duesseldorf.de
      • Contact: Raphael Bruno, MD; Phone Number: 18800 +4921181; Email: raphael.bruno@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control Arm; Patients in the control arm receive no virtual reality assisted information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay in days	Primary endpoint is the mean hospital stay in each group in days.	from start of hospitalizations until hospital leave up until day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental state on the day before the procedure as assessed by visual analog scale	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.	1 day before procedure
Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.	1 day before procedure
Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using Hospital Anxiety and Depression Scale German Version questionnaire. Anxiety scale in the questionnaire has values from 0 to 21 and Depression scale has values from 0 to 21. Lesser values denote less anxiety or depression.	1 day before procedure
Anxiety during the procedure as assessed by visual analog scale	Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.	during procedure
Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire	Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.	during procedure
Pain during the procedure	Pain can occur despite analgesia during an elective procedure such as TAVI. Pain is considered a trigger and amplifier of delirium. Patients are asked to quantify their pain on a visual analog scale during the procedure (time point: procedure performed but still in the hybrid operating room). Here, 0 corresponds to no pain and 10 to the maximum imaginable pain.	during procedure
Anxiety/stress before, during, and after surgery (measured as serum cortisol)	Anxiety and psychological stress are common before and during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients will have routine blood samples taken before, during, and after the procedure. From these, the parameter cortisol in serum is additionally determined optionally in the context of this study. Serum cortisol is an established parameter to quantify anxiety and stress, especially intraindividually.	on the 1 day before, during and on day 1-3 after procedure
Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).	Patients will have saliva samples taken before, during and after the procedure. From these, the parameters cortisol and alpha-amylase are additionally determined on an optional basis within the scope of this study. Both parameters are considered established to quantify anxiety and stress especially intraindividually.	on the 1 day before, during and on day 1-3 after procedure
Knowledge test after informed consent	In order to test to what extent the addition of a combination of different learning modalities (acoustic, visual, written, haptic) implemented in virtual reality to the medico-legal informed consent is superior to the standard informed consent, a survey is conducted after the informed consent.	1 day before procedure after informed consent
Major bleeding and minor bleeding during hospitalization.	Bleeding is a typical complication after cardio-vascular interventional procedures. Unawareness, disorientation, falls, and delirium favor the occurrence of bleeding. After hospital discharge, the occurrence of bleeding is recorded according to Valve Academic Research Consortium-2 consensus document (VARC), which is based on the bleeding academic research consortium (BARC) classification.	at hospital leave up to 360 days after procedure
Survival / rehospitalization at 6 and 12 months	After 6 and 12 months patients are contacted and information is gathered about survival of the patients and possible rehospitalization events.	after 6 and 12 months after hospital leave
Maximum length of hospital stay, in days	In addition to the mean hospital stay in days, a maximum hospital stay is also calculated.	at hospital leave up to 360 days after procedure

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Christian Jung, Prof MD PhD, Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: VRAP-Heart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No