Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions

Heinrich-Heine University, Duesseldorf500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Cardiac Imaging Techniques

Interventions

Data analysisDEVICE

data parameters Analysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, Germany

Outcomes

Primary Outcomes

Comparison of procedure time

During interventions with and without the use of EchoNavigator System Release II

Time frame: baseline

Secondary Outcomes

Comparison of area dose product

During procedures with and without the use of EchoNavigator System Release II

Time frame: baseline

Comparison of contrast agent amount

During procedures with and without the use of EchoNavigator System Release II

Time frame: baseline

Comparison of data measurements of fluoroscopy time

During procedures with and without the use of EchoNavigator System Release II

Time frame: baseline

Comparison of duration of the transeptal punction

During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II.

Time frame: baseline

Data from ClinicalTrials.gov

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