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

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT01821651

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases	Device: HeartNavigator Device: EchoNav Other: Control-Group EN Other: Control-group HN	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HeartNavigator Group with HeartNavigator-Software	Device: HeartNavigator Procedure with software Other Names: HeartNavigator, procedure with software
Active Comparator: Control Control-group without HeartNavigator-Software	Other: Control-group HN Procedure without software Other Names: Compare to HeartNavigator-group
Experimental: EchoNav Group with EchoNav-Software	Device: EchoNav Procedure with software Other Names: EchoNav, procedure with software
Active Comparator: Conrol Control-group without EchoNav-Software	Other: Control-Group EN Procedure without software Other Names: Compare to EchoNav-group

Outcome Measures

Primary Outcome Measures

Radiation Dose (mSv) administered to each patient [Day of intervention (day 1)]
At the end of the procedure the recorded radiation-dose is assessed.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.