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

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01821651
• Other study ID #: HOR-1
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2012
• Last updated: June 18, 2013
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2013
• Source: University of Zurich
• Contact: Simon Sündermann, MD
• Email: simon.suendermann[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• HeartNavigator
Procedure with software
• EchoNav
Procedure with software

Other:
• Control-Group EN
Procedure without software
• Control-group HN
Procedure without software

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiovascular Surgery	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Dose (mSv) administered to each patient	At the end of the procedure the recorded radiation-dose is assessed.	Day of intervention (day 1)	No
Secondary	Duration of the intervention (minutes)	At the end of the procedure the skin-to-skin-time is assessed.	Day of intervention (day 1)	No
Secondary	Contrast agent dose (ml)	At the end of the procedure the recorded contrast agent dose is assessed.	Day of intervention (day 1)	No
Secondary	Increased quality of care (EchoNav group)	Usually 1 to 5 days after intervention	Discharge: 1 to 5 days after intervention	No
Secondary	Degree of Mitral Regurgitation (EchoNav group)	Usually 1 to 5 days after intervention	Discharge: 1 to 5 days after intervention	No
Secondary	Postinterventional transvalvular gradient	Catheter-based direct measurement	Up to 7 days after intervention	No