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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: HeartNavigator
* Device: EchoNav
* Other: Control-Group EN
* Other: Control-group HN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartNavigator<br>Group with HeartNavigator-Software | Device: HeartNavigator<br>* Procedure with software<br>* Other names: HeartNavigator, procedure with software;|
| Active Comparator: Control<br>Control-group without HeartNavigator-Software | Other: Control-group HN<br>* Procedure without software<br>* Other names: Compare to HeartNavigator-group;|
| Experimental: EchoNav<br>Group with EchoNav-Software | Device: EchoNav<br>* Procedure with software<br>* Other names: EchoNav, procedure with software;|
| Active Comparator: Conrol<br>Control-group without EchoNav-Software | Other: Control-Group EN<br>* Procedure without software<br>* Other names: Compare to EchoNav-group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dose (mSv) administered to each patient | At the end of the procedure the recorded radiation-dose is assessed. | Day of intervention (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the intervention (minutes) | At the end of the procedure the skin-to-skin-time is assessed. | Day of intervention (day 1) | 
| Contrast agent dose (ml) | At the end of the procedure the recorded contrast agent dose is assessed. | Day of intervention (day 1) | 
| Increased quality of care (EchoNav group) | Usually 1 to 5 days after intervention | Discharge: 1 to 5 days after intervention | 
| Degree of Mitral Regurgitation (EchoNav group) | Usually 1 to 5 days after intervention | Discharge: 1 to 5 days after intervention | 
| Postinterventional transvalvular gradient | Catheter-based direct measurement | Up to 7 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, MitraClip, image modality, echocardiography, angiography