Use of Standardized Diagnostic Imaging Data for Image Fus... | NCT01821651

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

NCT01821651

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jun 19, 2013Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Heart Valve Diseases

Interventions

HeartNavigator
EchoNav
Control-Group EN
Control-group HN

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Dec 10, 2012

First Submission Date that Met QC Criteria

Mar 29, 2013

First Posted Date

Apr 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HeartNavigator	Experimental	Group with HeartNavigator-Software	Device: HeartNavigator
Control	Active Comparator	Control-group without HeartNavigator-Software	Other: Control-group HN
EchoNav	Experimental	Group with EchoNav-Software	Device: EchoNav
Conrol	Active Comparator	Control-group without EchoNav-Software	Other: Control-Group EN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HeartNavigator	Device	Procedure with software	HeartNavigator	HeartNavigator, procedure with software

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simon Sündermann, MD	Contact			simon.suendermann@usz.ch
Volkmar Falk, Prof MD	Contact			volkmar.falk@usz.ch

Overall Officials

Name	Affiliation	Role
Volkmar Falk, Prof MD	University Hospital Zurich, Division of Cardiovascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Cardiovascular Surgery	Recruiting	Zurich	Canton of Zurich	8091	Switzerland

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases