Clinical trial NCT01821651: Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
Official title: Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Keywords: TAVI
MitraClip
image modality
echocardiography
angiography
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Radiation Dose (mSv) administered to each patient
timeFrame: Day of intervention (day 1)
Secondary outcomes:
measure: Duration of the intervention (minutes)
timeFrame: Day of intervention (day 1)
measure: Contrast agent dose (ml)
timeFrame: Day of intervention (day 1)
measure: Increased quality of care (EchoNav group)
timeFrame: Discharge: 1 to 5 days after intervention
measure: Degree of Mitral Regurgitation (EchoNav group)
timeFrame: Discharge: 1 to 5 days after intervention
measure: Postinterventional transvalvular gradient
timeFrame: Up to 7 days after intervention
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiovascular Surgery
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiovascular Surgery
name: Volkmar Falk, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: