Virtual Reality Assisted Conscious Sedation During TAVI (TAVI_VR)

Klinik für Kardiologie, Pneumologie und Angiologie

Status: Completed

Conditions: Severe Aortic Valve Stenosis; Anxiety; Pain

Treatments: Other: VR during TAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT04259723

19-007

Details and patient eligibility

About

Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Interventional transfemoral TAVI
• Informed consent
• Normal or corrected vision (through glasses)

Exclusion criteria

• Patients whose communication is limited due to a language barrier
• Patients who could not watch the 3D video due to uncorrectable vision
• all patients with transapical TAVI were also excluded.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: VR during TAVI

Control

No Intervention group