Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room

University of Zurich (UZH)

Status: Unknown

Conditions: Heart Valve Diseases

Treatments: Other: Control-group HN; Device: HeartNavigator; Other: Control-Group EN; Device: EchoNav

Study type: Interventional

Funder types: Other

Identifiers

NCT01821651

HOR-1

Details and patient eligibility

About

Objectives:

Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.

Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).

This pilot study aims at observing these aims on a small patient population and a control group.

Number of Subjects:

140 patients total in 6 groups:

• MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
• MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
• TAVI with HeartNavigator lead in (10)
• TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).

Full description

Medical Device:

HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.

EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients over 18 years of age.
• Ability and willingness to give informed consent.
• Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
• Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).

Exclusion criteria

• Contraindications on ethical grounds,
• Women who are pregnant or breast feeding,
• Emergency cases,
• Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
• Known renal insufficiency (GFR < 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
• Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
• Known or suspected drug or alcohol abuse,
• Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
• Patient is unable or unwilling to cooperate with the study protocol.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

HeartNavigator

Experimental group

Description:

Group with HeartNavigator-Software

Treatment:

Device: HeartNavigator

Control

Active Comparator group

Description:

Control-group without HeartNavigator-Software

Treatment:

Other: Control-group HN

EchoNav

Experimental group

Description:

Group with EchoNav-Software

Treatment:

Device: EchoNav

Conrol

Active Comparator group

Description:

Control-group without EchoNav-Software

Treatment:

Other: Control-Group EN