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

NCT05552352 | Recruiting

• 1 other identifier: VRAP-Heart
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Severe Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Mental state on the day before the procedure as assessed by visual analog scale

  1 day before procedure

• Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire

  1 day before procedure

• Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire

  1 day before procedure

• Anxiety during the procedure as assessed by visual analog scale

  during procedure

• Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire

  during procedure

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

Virtual Reality assisted information 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Court ordered placement in an institution
• Any psychosocial condition that makes compliance with the protocol unlikely

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Edwards Lifesciences: collaborator

Study Sites (2)

Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

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

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Jung, Prof MD PhD

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Jung, Prof MD PhD

CONTACT

+49 211 81; christian.jung@med.uni-duesseldorf.de

Raphael Bruno, MD

CONTACT

+49 211 81; raphael.bruno@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-armed, randomized with controlled parallel groups.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 23, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)