Clinical trial NCT02608008: Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions
Official title: Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Imaging Techniques
Keywords: 3D-Ultrasound
Live X-rays
EchoNavigator System
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male or female patients undergoing structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA) with or without the periintervention use of the EchoNavigator System Release II.

Brief summary: The purpose of this study is to collect data regarding the safety and efficacy of EchoNavigator System Release II during structural heart interventions in the clinical practice. Data of procedures with and without the use of EchoNavigator System Release II will be collected, analysed and evaluated.

Detailed description: EchoNavigator System Release II is a CE certified innovative periinterventional imaging modality used in our clinic of cardiology, pulmonology and angiology during structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA). During this interventions EchoNavigator is able to combine live X-ray Images and 3D Echo guidance to enhance the efficiency of the procedure.

Specific periprocedural data parameter, e.g. procedure duration, radiation time, radiation dose, transseptal punction time (e.g.LAA) and contrast agent amount will be collected and analysed. The same data characteristics from the same procedures but without the periinterventional use of the EchoNavigator System Release II will be collected, analysed and compared with the data described above. A retrospective data collection between 2013 - 2017 of n=500 patients will be conducted.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients of any ethnic origin aged \> 18 years
* Signed and dated informed consent for the prospective study part

Exclusion Criteria:

* \< 18 year

Primary outcomes:
measure: Comparison of procedure time
timeFrame: baseline
Secondary outcomes:
measure: Comparison of area dose product
timeFrame: baseline
measure: Comparison of contrast agent amount
timeFrame: baseline
measure: Comparison of data measurements of fluoroscopy time
timeFrame: baseline
measure: Comparison of duration of the transeptal punction
timeFrame: baseline
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References: