Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
NCT ID: NCT01821651
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2012-01-31
2014-01-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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HeartNavigator
Group with HeartNavigator-Software
HeartNavigator
Procedure with software
Control
Control-group without HeartNavigator-Software
Control-group HN
Procedure without software
EchoNav
Group with EchoNav-Software
EchoNav
Procedure with software
Conrol
Control-group without EchoNav-Software
Control-Group EN
Procedure without software
Interventions
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HeartNavigator
Procedure with software
EchoNav
Procedure with software
Control-Group EN
Procedure without software
Control-group HN
Procedure without software
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Volkmar Falk, Prof MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Division of Cardiovascular Surgery
Locations
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University Hospital Zurich, Division of Cardiovascular Surgery
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Other Identifiers
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HOR-1
Identifier Type: -
Identifier Source: org_study_id
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