Heart Valve Diseases
Conditions
Keywords
TAVI, MitraClip, image modality, echocardiography, angiography
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.
Interventions
DEVICEHeartNavigator
Procedure with software
DEVICEEchoNav
Procedure with software
OTHERControl-Group EN
Procedure without software
OTHERControl-group HN
Procedure without software
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Contacts
Primary ContactSimon Sündermann, MD
Backup ContactVolkmar Falk, Prof MD
Outcome results
None listed